Viewing Study NCT00594568

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-24 @ 6:27 PM

Ignite Modification Date: 2026-01-16 @ 8:06 PM

Study NCT ID: NCT00594568

Status: COMPLETED

Last Update Posted: 2015-03-17

First Post: 2008-01-11

Is Gene Therapy: True

Has Adverse Events: True

Brief Title: Effect of LY450139 on the Long Term Progression of Alzheimer's Disease

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C484278', 'term': 'N2-((2S)-2-(3,5-difluorophenyl)-2-hydroxyethanoyl)-N1-((7S)-5-methyl-6-oxo-6,7-dihydro-5H-dibenzo(b,d)azepin-7-yl)-L-alaninamide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Outcomes with 4-week after study drug cessation timeframe=All dosing stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening for LY450139 participants; followed for 32 weeks; not all assessments were made.'}}, 'adverseEventsModule': {'description': 'Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo - Initial Treatment Period (NT)', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.', 'otherNumAtRisk': 501, 'otherNumAffected': 262, 'seriousNumAtRisk': 501, 'seriousNumAffected': 72}, {'id': 'EG001', 'title': '100 mg LY450139 - NT', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.', 'otherNumAtRisk': 507, 'otherNumAffected': 310, 'seriousNumAtRisk': 507, 'seriousNumAffected': 123}, {'id': 'EG002', 'title': '140 mg LY450139 - NT', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.', 'otherNumAtRisk': 529, 'otherNumAffected': 385, 'seriousNumAtRisk': 529, 'seriousNumAffected': 132}, {'id': 'EG003', 'title': 'Placebo - Delayed Start Period (DO)', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.', 'otherNumAtRisk': 192, 'otherNumAffected': 0, 'seriousNumAtRisk': 192, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': '100 mg LY450139 - DO', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.', 'otherNumAtRisk': 153, 'otherNumAffected': 0, 'seriousNumAtRisk': 153, 'seriousNumAffected': 9}, {'id': 'EG005', 'title': '140 mg LY450139 - DO', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.', 'otherNumAtRisk': 124, 'otherNumAffected': 0, 'seriousNumAtRisk': 124, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'Placebo- Safety FU Period (SFU)', 'description': 'For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.', 'otherNumAtRisk': 290, 'otherNumAffected': 0, 'seriousNumAtRisk': 290, 'seriousNumAffected': 12}, {'id': 'EG007', 'title': '100 mg LY450139- SFU', 'description': 'For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.', 'otherNumAtRisk': 223, 'otherNumAffected': 0, 'seriousNumAtRisk': 223, 'seriousNumAffected': 22}, {'id': 'EG008', 'title': '140 mg LY450139- SFU', 'description': 'For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.', 'otherNumAtRisk': 214, 'otherNumAffected': 0, 'seriousNumAtRisk': 214, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 93, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 67, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 87, 'numAffected': 71}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 27, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 69, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 71, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 50, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 67, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 40, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 39, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 39, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 44, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 44, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 50, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 45, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 25, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 48, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 37, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 61, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 41, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 30, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 46, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 42, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 57, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 36, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 36, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 36, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hair colour changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 64, 'numAffected': 63}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 106, 'numAffected': 99}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 25, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 38, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 43, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 50, 'numAffected': 43}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Venous insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 501, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 507, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 529, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 192, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 290, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 223, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.19', 'spread': '0.54', 'groupId': 'OG000'}, {'value': '7.29', 'spread': '0.57', 'groupId': 'OG001'}, {'value': '7.68', 'spread': '0.59', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.134', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.045', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.610', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "ADAS-Cog11 was used as a primary efficacy measure. It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'PRIMARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug", 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.59', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '7.57', 'spread': '0.91', 'groupId': 'OG001'}, {'value': '7.90', 'spread': '0.90', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.296', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.172', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.746', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 16 weeks following treatment cessation', 'description': "ADAS-Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'PRIMARY', 'title': "Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.76', 'spread': '0.72', 'groupId': 'OG000'}, {'value': '-10.13', 'spread': '0.77', 'groupId': 'OG001'}, {'value': '-12.70', 'spread': '0.79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.166', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.014', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'PRIMARY', 'title': "Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug", 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.26', 'spread': '1.14', 'groupId': 'OG000'}, {'value': '-9.15', 'spread': '1.28', 'groupId': 'OG001'}, {'value': '-11.73', 'spread': '1.26', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.935', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.068', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.070', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 16 weeks following treatment cessation', 'description': "ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '309', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '245', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.86', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '-5.97', 'spread': '2.50', 'groupId': 'OG001'}, {'value': '-19.95', 'spread': '2.58', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 52 weeks', 'description': 'Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '-0.11', 'spread': '0.02', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.147', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.604', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': 'Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'title': 'Left Hippocampal Volume', 'categories': [{'measurements': [{'value': '-96.54', 'spread': '10.73', 'groupId': 'OG000'}, {'value': '-75.34', 'spread': '11.06', 'groupId': 'OG001'}, {'value': '-107.62', 'spread': '11.38', 'groupId': 'OG002'}]}]}, {'title': 'Right Hippocampal Volume', 'categories': [{'measurements': [{'value': '-108.69', 'spread': '11.56', 'groupId': 'OG000'}, {'value': '-93.89', 'spread': '12.19', 'groupId': 'OG001'}, {'value': '-112.40', 'spread': '12.52', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.143', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the p-value for the Left Hippocampal Volume', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.464', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This is the p-value for the Left Hippocampal Volume', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.025', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This is the p-value for the Left Hippocampal Volume', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.347', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'This is the p-value for the Right Hippocampal Volume', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.820', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This is the p-value for the Right Hippocampal Volume', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.243', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'This is the p-value for the Right Hippocampal Volume', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.', 'unitOfMeasure': 'cubic millimeter (mm^3)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '0.09', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.784', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.931', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.718', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': "A radioactive tracer for PET that is a ligand for amyloid called AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.", 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.11', 'spread': '92.02', 'groupId': 'OG000'}, {'value': '20.50', 'spread': '69.54', 'groupId': 'OG001'}, {'value': '61.00', 'spread': '59.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.634', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.901', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.659', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'LY450139 Population Pharmacokinetics: Clearance of LY450139', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'spread': '26.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks, 12 weeks, and 52 weeks', 'description': 'Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.', 'unitOfMeasure': 'liter per hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of clearance.'}, {'type': 'SECONDARY', 'title': 'LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139', 'denoms': [{'units': 'Participants', 'counts': [{'value': '974', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'LY450139', 'description': 'Participants received 60 milligram LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.8', 'spread': '26.1', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '6 weeks, 12 weeks, and 52 weeks', 'description': 'Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.', 'unitOfMeasure': 'liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population (N=974) included all participants randomized to LY450139 with sufficient drug concentration and dosing information to allow estimation of volume of distribution.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '215', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.52', 'spread': '0.58', 'groupId': 'OG000'}, {'value': '7.98', 'spread': '0.61', 'groupId': 'OG001'}, {'value': '8.33', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.062', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.022', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.669', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': 'ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks", 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.42', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '8.97', 'spread': '0.67', 'groupId': 'OG001'}, {'value': '9.48', 'spread': '0.69', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.071', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.571', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': 'ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '376', 'groupId': 'OG000'}, {'value': '289', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.95', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-3.14', 'spread': '0.27', 'groupId': 'OG001'}, {'value': '-3.71', 'spread': '0.27', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.518', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.013', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.072', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': 'MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The total score ranges from 0 to 30; Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}, {'value': '195', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.31', 'spread': '0.17', 'groupId': 'OG000'}, {'value': '2.73', 'spread': '0.18', 'groupId': 'OG001'}, {'value': '3.04', 'spread': '0.18', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.198', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '369', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.92', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '3.31', 'spread': '0.79', 'groupId': 'OG001'}, {'value': '4.15', 'spread': '0.81', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.127', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.016', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.381', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '374', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}, {'value': '275', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.41', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '-7.49', 'spread': '1.20', 'groupId': 'OG001'}, {'value': '-5.33', 'spread': '1.22', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.005', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.141', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '0.83', 'spread': '0.08', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.337', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.018', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.157', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.', 'unitOfMeasure': 'hospitalizations/participant', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug", 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.97', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '8.27', 'spread': '0.95', 'groupId': 'OG001'}, {'value': '8.41', 'spread': '0.94', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.186', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.149', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.889', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 16 weeks following treatment cessation', 'description': 'ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug", 'denoms': [{'units': 'Participants', 'counts': [{'value': '204', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '146', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.90', 'spread': '0.93', 'groupId': 'OG000'}, {'value': '9.30', 'spread': '1.06', 'groupId': 'OG001'}, {'value': '9.89', 'spread': '1.04', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.202', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.075', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.616', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), 16 weeks following treatment cessation', 'description': 'ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': "Semi-structured interview; Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains. Total score (SB) ranges: 0 to 18; Higher scores=greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed.", 'reportingStatus': 'POSTED', 'populationDescription': 'August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': "NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed", 'reportingStatus': 'POSTED', 'populationDescription': 'August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': 'MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 4 Weeks After Cessation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': "EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges from 0 to 100; Lower score indicates greater disease severity. LS Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed.", 'reportingStatus': 'POSTED', 'populationDescription': 'August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': 'RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'August 2010: all dosing was stopped after protocol-specified interim review showed dose-dependent cognitive/functional worsening of LY450139-treated participants. Participants were followed off-dose for 32 weeks. No analysis was performed at 4 weeks after cessation of drug since this outcome measure was not assessed during the follow-up period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '-86.16', 'spread': '50.89', 'groupId': 'OG000'}, {'value': '23.27', 'spread': '34.55', 'groupId': 'OG001'}, {'value': '-40.51', 'spread': '31.68', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'OG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'OG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.75', 'spread': '7.67', 'groupId': 'OG000'}, {'value': '-6.26', 'spread': '5.46', 'groupId': 'OG001'}, {'value': '-5.13', 'spread': '5.04', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.', 'unitOfMeasure': 'picogram per milliliter (pg/mL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all randomized participants who received at least 1 dose of study medication with baseline and at least 1 post baseline evaluable data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'FG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'FG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}], 'periods': [{'title': 'Initial Treatment', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '501'}, {'groupId': 'FG001', 'numSubjects': '507'}, {'groupId': 'FG002', 'numSubjects': '529'}]}, {'type': 'Intent-to-treat (ITT)', 'achievements': [{'comment': 'ITT population included all randomized participants (pts) who had at least 1 dose of study drug.', 'groupId': 'FG000', 'numSubjects': '501'}, {'comment': 'ITT population included all randomized participants who had at least 1 dose of study drug.', 'groupId': 'FG001', 'numSubjects': '506'}, {'comment': 'ITT population included all randomized participants who had at least 1 dose of study drug.', 'groupId': 'FG002', 'numSubjects': '527'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '312'}, {'groupId': 'FG001', 'numSubjects': '354'}, {'groupId': 'FG002', 'numSubjects': '408'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '121'}, {'groupId': 'FG002', 'numSubjects': '144'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '46'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '193'}, {'groupId': 'FG001', 'numSubjects': '142'}, {'groupId': 'FG002', 'numSubjects': '147'}]}, {'type': 'Caregiver decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'Abnormal lab/electrocardiogram (ECG)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Entry criteria exclusion', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Delayed Start', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '121'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '76'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '98'}, {'groupId': 'FG001', 'numSubjects': '77'}, {'groupId': 'FG002', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Caregiver Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '77'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '59'}]}]}, {'title': 'Safety Follow Up (SFU)-Optional', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'SFU was optional; pts entered from initial treatment and delayed start or did not enter SFU.', 'groupId': 'FG000', 'numSubjects': '290'}, {'comment': 'SFU was optional; pts entered from initial treatment and delayed start or did not enter SFU.', 'groupId': 'FG001', 'numSubjects': '223'}, {'comment': 'SFU was optional, pts entered from initial treatment and delayed start or did not enter SFU.', 'groupId': 'FG002', 'numSubjects': '214'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '229'}, {'groupId': 'FG001', 'numSubjects': '168'}, {'groupId': 'FG002', 'numSubjects': '172'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '42'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Caregiver Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'No safety visit or follow up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '501', 'groupId': 'BG000'}, {'value': '506', 'groupId': 'BG001'}, {'value': '527', 'groupId': 'BG002'}, {'value': '1534', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.'}, {'id': 'BG001', 'title': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.'}, {'id': 'BG002', 'title': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.9', 'spread': '8.1', 'groupId': 'BG000'}, {'value': '73.6', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '73.9', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '73.8', 'spread': '8.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '278', 'groupId': 'BG000'}, {'value': '279', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}, {'value': '820', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '223', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}, {'value': '714', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '413', 'groupId': 'BG000'}, {'value': '428', 'groupId': 'BG001'}, {'value': '441', 'groupId': 'BG002'}, {'value': '1282', 'groupId': 'BG003'}]}]}, {'title': 'African', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'East Asian', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '143', 'groupId': 'BG003'}]}]}, {'title': 'West Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}, {'value': '585', 'groupId': 'BG003'}]}]}, {'title': 'Finland', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '45', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '121', 'groupId': 'BG003'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) Score", 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '9.1', 'groupId': 'BG000'}, {'value': '22.5', 'spread': '8.9', 'groupId': 'BG001'}, {'value': '23.1', 'spread': '8.8', 'groupId': 'BG002'}, {'value': '22.8', 'spread': '8.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'ADAS-Cog11 consists of 11 items assessing areas of function most typically impaired in AD: orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': "Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score", 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '12.4', 'groupId': 'BG002'}, {'value': '61.1', 'spread': '12.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': "The ADCS-ADL Inventory Score is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1537}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'dispFirstSubmitDate': '2011-08-09', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-13', 'studyFirstSubmitDate': '2008-01-11', 'dispFirstSubmitQcDate': '2011-08-09', 'resultsFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2008-01-11', 'dispFirstPostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-09-22', 'studyFirstPostDateStruct': {'date': '2008-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 76 Weeks", 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "ADAS-Cog11 was used as a primary efficacy measure. It consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication."}, {'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) Score at 16 Weeks After Cessation of Study Drug", 'timeFrame': 'Baseline (randomization), 16 weeks following treatment cessation', 'description': "ADAS-Cog11 consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication."}, {'measure': "Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 76 Weeks", 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication."}, {'measure': "Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score at 16 Weeks After Cessation of Study Drug", 'timeFrame': 'Baseline (randomization), 16 weeks following treatment cessation', 'description': "ADCS-ADL is a 23-item inventory developed as a Rater-administered questionnaire answered by the participant's caregiver. It measures performance of basic and instrumental activities of daily living by participants. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication."}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at 52 Weeks', 'timeFrame': 'Baseline (randomization), 52 weeks', 'description': 'Concentration of amino acid peptide, known as Aβ 1-42, in plasma. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.'}, {'measure': 'Change From Baseline in Positron Emission Tomography (PET) Using Fluorine-18 Fluorodeoxyglucose (18F-FDG) at 76 Weeks', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': 'Measurement of local cerebral glucose metabolism by PET using the radioactive tracer 18F-FDG. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the Pons. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.'}, {'measure': 'Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) up to 76 Weeks', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'The vMRI assessment of left and right hippocampal volume is reported. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.'}, {'measure': 'Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45 PET) up to 76 Weeks', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': "A radioactive tracer for PET that is a ligand for amyloid called AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio (SUVR) normalized to the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator."}, {'measure': 'Change From Baseline in Tau Concentration in Spinal Fluid up to 76 Weeks', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'Concentration of total tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.'}, {'measure': 'LY450139 Population Pharmacokinetics: Clearance of LY450139', 'timeFrame': '6 weeks, 12 weeks, and 52 weeks', 'description': 'Model estimated apparent oral clearance. Clearance is defined as the volume of plasma that is completely cleared of drug (LY450139) per unit time.'}, {'measure': 'LY450139 Population Pharmacokinetics: Volume of Distribution of LY450139', 'timeFrame': '6 weeks, 12 weeks, and 52 weeks', 'description': 'Model-estimated apparent volume of distribution. Volume of distribution is a measure of the extent to which the drug distributes in the body.'}, {'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 76 Weeks", 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': 'ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.'}, {'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 76 Weeks", 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': 'ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.'}, {'measure': 'Change From Baseline in Mini Mental State Examination (MMSE) Score at 76 Weeks', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': 'MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures) in elderly participants. The total score ranges from 0 to 30; Lower score indicates greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.'}, {'measure': 'Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 76 Weeks', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication."}, {'measure': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 76 Weeks', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication."}, {'measure': 'Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 76 Weeks', 'timeFrame': 'Baseline (randomization), 76 weeks', 'description': "EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numerals 1-3 are not added for total score. VAS assesses caregiver's impression of participant's overall health state; scores range from 0 to 100; Lower scores indicate greater disease severity. Least Squares (LS) Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication."}, {'measure': 'Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) up to 76 Weeks', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'Assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) was collected from baseline and follow-up interviews; Reported number of hospitalizations per participant up to 76 weeks. Least Squares (LS) Mean value was controlled for age and investigator.'}, {'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog12) Score at 16 Weeks After Cessation of Study Drug", 'timeFrame': 'Baseline (randomization), 16 weeks following treatment cessation', 'description': 'ADAS-Cog12 is ADAS-Cog11 augmented with delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication.'}, {'measure': "Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) Score at 16 Weeks After Cessation of Study Drug", 'timeFrame': 'Baseline (randomization), 16 weeks following treatment cessation', 'description': 'ADAS-Cog14 is ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, concomitant standard of care (SOC) medication.'}, {'measure': 'Change From Baseline in Clinical Dementia Rating-Sum of Boxes (CDR-SB) Score at 4 Weeks After Cessation of Study Drug', 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': "Semi-structured interview; Participant's cognitive status rated across 6 domains of functioning: memory, orientation, judgment/problem solving, community affairs, home/hobbies, personal care. Severity score assigned for each of 6 domains. Total score (SB) ranges: 0 to 18; Higher scores=greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants followed off-dose for 32 weeks, but CDR-SB not assessed."}, {'measure': 'Change From Baseline in Neuropsychiatric Inventory (NPI) Score at 4 Weeks After Cessation of Study Drug', 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': "NPI assesses psychopathology in participants with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with participant's behavior. Total score ranges from 12 to 144; Higher scores indicate greater disease severity. Least Squares (LS) Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but NPI was not assessed"}, {'measure': 'Change From Baseline in Mini Mental State Examination (MMSE) Score at 4 Weeks After Cessation of Study Drug', 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': 'MMSE is a brief screening instrument used to assess cognitive function (orientation, memory, attention, ability to name objects, follow verbal/written commands, write a sentence, copy figures) in elderly participants. Total score ranges from 0 to 30; Lower score indicates greater disease severity. LS Mean value was controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but MMSE was not assessed.'}, {'measure': 'Change From Baseline in EuroQol 5-Dimensional Health-Related Quality of Life Scale Proxy Version (EQ-5D Proxy) Visual Analog Scale (VAS) Score at 4 Weeks After Cessation of Study Drug', 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': "EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression. 3 severity levels: no, some, severe problems. VAS assesses caregiver's impression of participant's health state; score ranges from 0 to 100; Lower score indicates greater disease severity. LS Mean value controlled for baseline value, age, investigator, visit, and concomitant standard of care (SOC) medication. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but EQ-5D VAS was not assessed."}, {'measure': 'Change From Baseline in Resource Utilization in Dementia-Lite (RUD-Lite) Score (Number of Hospitalizations) at 4 Weeks After Cessation of Study Drug', 'timeFrame': 'Baseline (randomization), 4 weeks following treatment cessation', 'description': 'RUD-Lite assesses healthcare resource utilization (formal and informal care). Information gathered on both caregivers (care-giving time, work status) and participants (accommodation, healthcare resource utilization) is collected. Reported number of participant hospitalizations. Least Squares (LS) Mean value controlled for age and investigator. All LY450139 dosing was stopped due to evidence of dose-dependent cognitive/functional worsening. Participants were followed off-dose for 32 weeks, but RUD-Lite was not assessed.'}, {'measure': 'Change From Baseline in Amyloid Beta (Aβ) 1-42 Concentration in Spinal Fluid up to 76 Weeks', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'Concentration of an amino peptide known as Aβ 1-42 in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.'}, {'measure': 'Change From Baseline in Phosphorylated-Tau (P-Tau) Concentration in Spinal Fluid', 'timeFrame': 'Baseline (randomization), up to 76 weeks', 'description': 'Concentration of p-tau in spinal fluid. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '26402769', 'type': 'DERIVED', 'citation': "Liu-Seifert H, Siemers E, Price K, Han B, Selzler KJ, Henley D, Sundell K, Aisen P, Cummings J, Raskin J, Mohs R; Alzheimer's Disease Neuroimaging Initiative. Cognitive Impairment Precedes and Predicts Functional Impairment in Mild Alzheimer's Disease. J Alzheimers Dis. 2015;47(1):205-14. doi: 10.3233/JAD-142508."}, {'pmid': '26120369', 'type': 'DERIVED', 'citation': "Henley DB, Dowsett SA, Chen YF, Liu-Seifert H, Grill JD, Doody RS, Aisen P, Raman R, Miller DS, Hake AM, Cummings J. Alzheimer's disease progression by geographical region in a clinical trial setting. Alzheimers Res Ther. 2015 Jun 25;7(1):43. doi: 10.1186/s13195-015-0127-0. eCollection 2015."}, {'pmid': '26064192', 'type': 'DERIVED', 'citation': "Doody RS, Raman R, Sperling RA, Seimers E, Sethuraman G, Mohs R, Farlow M, Iwatsubo T, Vellas B, Sun X, Ernstrom K, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study. Peripheral and central effects of gamma-secretase inhibition by semagacestat in Alzheimer's disease. Alzheimers Res Ther. 2015 Jun 10;7(1):36. doi: 10.1186/s13195-015-0121-6. eCollection 2015."}, {'pmid': '23883379', 'type': 'DERIVED', 'citation': "Doody RS, Raman R, Farlow M, Iwatsubo T, Vellas B, Joffe S, Kieburtz K, He F, Sun X, Thomas RG, Aisen PS; Alzheimer's Disease Cooperative Study Steering Committee; Siemers E, Sethuraman G, Mohs R; Semagacestat Study Group. A phase 3 trial of semagacestat for treatment of Alzheimer's disease. N Engl J Med. 2013 Jul 25;369(4):341-50. doi: 10.1056/NEJMoa1210951."}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': "Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no cure. AD causes brain cells to die. AD is thought to be caused by an excess of beta-amyloid (β-amyloid), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have these amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme gamma-secretase (γ-secretase) lowers the production of β-amyloid. Semagacestat (LY450139) is a functional γ-secretase inhibitor and was shown to lower β-amyloid in blood and spinal fluid in humans tested thus far and in blood, spinal fluid, and brain in animals tested thus far. This study used several different tests to measure the effect of semagacestat on both β-amyloid and amyloid plaques for some participants. The build-up of amyloid plaques was measured by a brain scan that takes a picture of amyloid plaques in the brain. Other tests measured the overall function of the brain and brain size in some participants. In this trial, participants who initially received placebo (inactive sugar pill) were, at a certain point in the study, switched over to active drug, semagacestat. In other words, all participants could eventually receive active drug. Participation could last approximately 2 years. Participants taking approved AD medications were permitted to participate in this study and continue taking these medications during the study. All participants who completed this study had the option to continue receiving semagacestat by participating in an open-label study.\n\nPreliminary results from this study (H6L-MC-LFAN \\[LFAN\\]) and another similar study (H6L-MC-LFBC \\[LFBC; NCT00762411\\]) showed semagacestat did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. Study drug was stopped in all studies. Studies LFAN, LFBC, and open-label H6L-MC-LFBF (LFBF; NCT01035138) were amended to continue collecting safety data, including cognitive scores, for at least 7 months. The Clinical Trial Registry (CTR) will reflect results of analyses from the original LFAN protocol in addition to those from the amended LFAN protocol."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meets criteria for mild to moderate Alzheimer's disease (AD) with Mini-Mental State Examination (MMSE) score of 16-26 at Visit 1\n* Modified Hachinski Ischemia Scale score of less than or equal to 4\n* Geriatric Depression Scale score of less than or equal to 6\n* A magnetic resonance imaging (MRI) or computerized tomography (CT) scan in the last 2 years with no findings inconsistent with a diagnosis of AD\n* If female, must be without menstruation for at least 12 consecutive months or have had both ovaries removed\n\nExclusion Criteria:\n\n* Is not capable of swallowing whole oral medication\n* Has serious or unstable illnesses\n* Does not have a reliable caregiver\n* Chronic alcohol or drug abuse within the past 5 years\n* Has ever had active vaccination for AD"}, 'identificationModule': {'nctId': 'NCT00594568', 'briefTitle': "Effect of LY450139 on the Long Term Progression of Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': "Effect of γ-Secretase Inhibition on the Progression of Alzheimer's Disease: LY450139 Versus Placebo", 'orgStudyIdInfo': {'id': '7666'}, 'secondaryIdInfos': [{'id': 'H6L-MC-LFAN', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': 'CTRI/2009/091/000090', 'type': 'REGISTRY', 'domain': 'India'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '100 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.', 'interventionNames': ['Drug: LY450139']}, {'type': 'EXPERIMENTAL', 'label': '140 mg LY450139', 'description': 'Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.', 'interventionNames': ['Drug: LY450139']}], 'interventions': [{'name': 'LY450139', 'type': 'DRUG', 'otherNames': ['semagacestat'], 'description': 'Administered orally once daily', 'armGroupLabels': ['100 mg LY450139', '140 mg LY450139']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally once daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06518', 'city': 'Hamden', 'state': 'Connecticut', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.39593, 'lon': -72.89677}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20057', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '34613', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33140', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33064', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '33716', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33351', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40503', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '21224', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.87813, 'lon': -73.19677}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '1425', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'X5004AOA', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.9681, 'lon': 151.13564}}, {'zip': '2013', 'city': 'Randwick, Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3220', 'city': 'Geelong', 'state': 'Victoria', 'country': 'Australia', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.48062, 'lon': -119.58584}}, {'zip': 'G1R 3X5', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'J1H1Z1', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Antofagasta', 'country': 'Chile', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -23.65094, 'lon': -70.39752}}, {'city': 'Concepción', 'country': 'Chile', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -36.82699, 'lon': -73.04977}}, {'zip': '6640870', 'city': 'Santiago', 'country': 'Chile', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Santiago', 'country': 'Chile', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'city': 'Valdivia', 'country': 'Chile', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -39.81422, 'lon': -73.24589}}, {'city': 'Viña del Mar', 'country': 'Chile', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.02457, 'lon': -71.55183}}, {'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'zip': '4000', 'city': 'Roskilde', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}, {'zip': '4000', 'city': 'Svendborg', 'country': 'Denmark', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.05982, 'lon': 10.60677}}, {'zip': '70210', 'city': 'Kuopio', 'country': 'Finland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - 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Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76036', 'city': 'Rouen', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '01307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '30559', 'city': 'Hanover', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}, {'zip': 'BY 80336', 'city': 'München', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': 'D-93053', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '57072', 'city': 'Siegen', 'country': 'Germany', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'zip': '600003', 'city': 'Chennai', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 13.08784, 'lon': 80.27847}}, {'zip': '400082', 'city': 'Hyderabaad', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.'}, {'zip': '700054', 'city': 'Kolkata', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 22.56263, 'lon': 88.36304}}, {'zip': '575002', 'city': 'Mangalore', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '400050', 'city': 'Mumbai', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'zip': '695011', 'city': 'Thiruvananthapuram', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 8.4855, 'lon': 76.94924}}, {'zip': '517507', 'city': 'Tirupati', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 13.63551, 'lon': 79.41989}}, {'zip': '221005', 'city': 'Varanasi', 'country': 'India', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 25.31668, 'lon': 83.01041}}, {'zip': '78306', 'city': 'Ashkelon', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.66926, 'lon': 34.57149}}, {'zip': '84170', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'zip': '31096', 'city': 'Haifa', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '91240', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '52661', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '20157', 'city': 'Milan', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '56126', 'city': 'Pisa', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00153', 'city': 'Rome', 'country': 'Italy', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '910-3113', 'city': 'Fukui', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.84214, 'lon': 135.54836}}, {'zip': '770-8076', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '761-0793', 'city': 'Kagawa', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.06667, 'lon': 131.03333}}, {'zip': '780-0842', 'city': 'Kochi', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 33.55, 'lon': 133.53333}}, {'zip': '590-0018', 'city': 'Osaka', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '770-8076', 'city': 'Tokushima', 'country': 'Japan', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 34.06667, 'lon': 134.56667}}, {'zip': '15402', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '81-361', 'city': 'Gdynia', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.51889, 'lon': 18.53188}}, {'zip': '92-216', 'city': 'Lodz', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-950', 'city': 'Lublin', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '61-606', 'city': 'Poznan', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '4094', 'city': 'Bellair', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -29.89195, 'lon': 30.95062}}, {'zip': '7530', 'city': 'Bellville', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.90022, 'lon': 18.62847}}, {'zip': '7925', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '6529', 'city': 'George', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.963, 'lon': 22.46173}}, {'zip': '1709', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '2132', 'city': 'Rosebank', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -33.95556, 'lon': 18.47417}}, {'zip': '7130', 'city': 'Somerset West', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -34.08401, 'lon': 18.82113}}, {'zip': '4319', 'city': 'Umhlanga', 'country': 'South Africa', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': -29.72528, 'lon': 31.08583}}, {'zip': '2006', 'city': 'Albacete', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 38.99424, 'lon': -1.85643}}, {'zip': '48903', 'city': 'Barakaldo', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'zip': '08014', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '10600', 'city': 'Plasencia', 'country': 'Spain', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 40.03116, 'lon': -6.08845}}, {'zip': '20502', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '43185', 'city': 'Mölndal', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}, {'zip': '60172', 'city': 'Norrköping', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}, {'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '45180', 'city': 'Uddevalla', 'country': 'Sweden', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 58.34784, 'lon': 11.9424}}, {'zip': 'BA1 3NG', 'city': 'Bath', 'state': 'Banes', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.3751, 'lon': -2.36172}}, {'zip': 'SO30 3JB', 'city': 'Southampton', 'state': 'Hants', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'L9 7LJ', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'G20 0XA', 'city': 'Glasgow', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}, {'zip': 'SN1 4JU', 'city': 'Swindon', 'state': 'Wilts', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.55797, 'lon': -1.78116}}, {'zip': 'BT9 7BL', 'city': 'Belfast', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}, {'zip': 'NE4 6BE', 'city': 'Newcastle', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 54.21804, 'lon': -5.88979}}, {'zip': 'ST4 6QG', 'city': 'Stoke-on-Trent', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.00415, 'lon': -2.18538}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}