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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 @ 7:08 PM

Ignite Modification Date: 2025-12-29 @ 1:14 AM

Study NCT ID: NCT02008357

Status: COMPLETED

Last Update Posted: 2023-12-28

First Post: 2013-12-06

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

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': 'D003072', 'term': 'Cognition Disorders'}], 'ancestors': [{'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C550616', 'term': 'solanezumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Per protocol and SAP, delayed-start analyses were not conducted because no treatment difference was observed at the end of the double-blind (placebo-controlled) period. Hence, data were not evaluated for outcome measure analyses (week 336), but safety data were analyzed for open-label extension period.'}}, 'adverseEventsModule': {'timeFrame': 'Double-blind (Placebo Controlled) Period (Baseline Up to Week 240); Open-label Extension Period (Week 240 Up to Week 444)', 'description': 'All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.', 'eventGroups': [{'id': 'EG000', 'title': 'Solanezumab: Double-blind (Placebo Controlled) Period', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.', 'otherNumAtRisk': 572, 'deathsNumAtRisk': 572, 'otherNumAffected': 531, 'seriousNumAtRisk': 572, 'deathsNumAffected': 6, 'seriousNumAffected': 171}, {'id': 'EG001', 'title': 'Placebo: Double-blind (Placebo Controlled) Period', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.', 'otherNumAtRisk': 591, 'deathsNumAtRisk': 591, 'otherNumAffected': 554, 'seriousNumAtRisk': 591, 'deathsNumAffected': 7, 'seriousNumAffected': 156}, {'id': 'EG002', 'title': 'Solanezumab/Solanezumab: Open-label Extension Period', 'description': 'Participants who received solanezumab in double-blind period were administered 1600 mg solanezumab IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.', 'otherNumAtRisk': 383, 'deathsNumAtRisk': 383, 'otherNumAffected': 286, 'seriousNumAtRisk': 383, 'deathsNumAffected': 7, 'seriousNumAffected': 51}, {'id': 'EG003', 'title': 'Placebo/Solanezumab: Open-label Extension Period', 'description': 'Participants who received placebo in double-blind period were administered 1600 mg solanezumab IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.', 'otherNumAtRisk': 401, 'deathsNumAtRisk': 401, 'otherNumAffected': 310, 'seriousNumAtRisk': 401, 'deathsNumAffected': 5, 'seriousNumAffected': 70}], 'otherEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 27, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 29, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 82, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 99, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 30, 'numAffected': 24}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 91, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 99, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 40, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 36, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 72, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 52, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 31, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 61, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 72, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 35, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 30, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Covid-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 111, 'numAffected': 105}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 113, 'numAffected': 108}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 23, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 53, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 47, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 172, 'numAffected': 117}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 183, 'numAffected': 121}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 18, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 78, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 94, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 16, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 32, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 298, 'numAffected': 174}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 348, 'numAffected': 198}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 50, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 54, 'numAffected': 46}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 149, 'numAffected': 82}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 139, 'numAffected': 92}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 49, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 50, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 50, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 32, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 77, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 64, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 266, 'numAffected': 170}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 278, 'numAffected': 156}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 90, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 95, 'numAffected': 71}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 34, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 43, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Meniscus injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Muscle strain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 46, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 39, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Skin abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 42, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 36, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 44, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 59, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vaccination complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 12, 'numAffected': 12}, {'groupId': 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'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ileostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lung lobectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Spinal fusion surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Transurethral prostatectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 238, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 234, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aortic dissection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Essential hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypertensive urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 572, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 591, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 383, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 401, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '403', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.43', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '-1.13', 'spread': '0.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.260', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.30', 'ciLowerLimit': '-0.816', 'ciUpperLimit': '0.220', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.26', 'statisticalMethod': 'Natural Cubic Spline (NCS) method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \\[none\\]-91 \\[best performance\\]) and Mini Mental State Examination (Range 0 \\[worst\\] - 30 \\[best performance\\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have a baseline score and at least 1 post-baseline assessment. Least square mean (LS) mean was derived using natural cubic spline models with factors for treatment, time, and covariates = age, baseline florbetapir cortical standardized uptake value ratio (SUVr) score, years of education, APOE4 carrier status (n),pacc components version type.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}, {'id': 'OG001', 'title': 'Placebo/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}], 'timeFrame': 'Baseline, Week 336', 'description': 'PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \\[none\\]-91 \\[best performance\\]) and Mini Mental State Examination (Range 0 \\[worst\\] - 30 \\[best performance\\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Function Index (CFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '422', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.94', 'spread': '0.20', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.20', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.100', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.47', 'ciLowerLimit': '-0.089', 'ciUpperLimit': '1.020', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.28', 'statisticalMethod': 'Natural Cubic Spline (NCS) method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week approximately 240', 'description': "The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and study partner/informant-reported outcome measure developed by the Alzheimer's Disease Cooperative Study (ADCS). This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A total score is calculated by combining participant-reported and an informant-reported scores, and ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment. LS mean was derived using natural cubic spline models with factors for treatment, time, and covariates = age, baseline florbetapir cortical SUVr score, years of education, APOE4 carrier status (n).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have a baseline score and at least 1 post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cognitive Function Index (CFI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}, {'id': 'OG001', 'title': 'Placebo/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}], 'timeFrame': 'Baseline, Week 336', 'description': "The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and study partner/informant-reported outcome measure developed by the ADCS. This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A total score is calculated by combining participant-reported and an informant-reported scores, and ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment.", 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '408', 'groupId': 'OG000'}, {'value': '423', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.29', 'spread': '0.24', 'groupId': 'OG000'}, {'value': '-1.70', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.082', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-1.265', 'ciUpperLimit': '0.076', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.34', 'statisticalMethod': 'Natural Cubic Spline (NCS) method', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'The ADCS-ADL-prevention questionnaire is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant\'s level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don\'t know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have a baseline score and at least 1 post-baseline assessment. LS mean was derived using natural cubic spline models with factors for treatment, time, and covariates = age, baseline florbetapir cortical SUVr score, years of education, APOE4 carrier status (n).'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}, {'id': 'OG001', 'title': 'Placebo/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}], 'timeFrame': 'Baseline, Week 336', 'description': 'The ADCS-ADL-prevention questionnaire is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant\'s level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don\'t know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The scores range from 0 to 45 with higher scores indicating less impairment. The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}, {'value': '477', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.066', 'spread': '0.0052', 'groupId': 'OG000'}, {'value': '0.108', 'spread': '0.0051', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.042', 'ciLowerLimit': '-0.057', 'ciUpperLimit': '-0.028', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0073', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'Deposition of abnormal tau protein in the brain associated with AD was assessed by quantitative positron emission tomography (PET) scan using flortaucipir F-18. Flortaucipir is an F-18-labeled small molecule that binds with high affinity and selectivity to aggregated tau, and provides a measure of aggregated tau deposition in the brain, expressed as flortaucipir SUVr. LS Mean was calculated using an analysis of covariance (ANCOVA) model with fixed effects of baseline florbetapir result, treatment, APOE4 Carrier Status (yes/no), and age at baseline', 'unitOfMeasure': 'standardized uptake value ratio (SUVr)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have a baseline score and at least 1 post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}], 'classes': [{'title': 'CSF Tau Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-17.201', 'spread': '23.5807', 'groupId': 'OG000'}, {'value': '-20.440', 'spread': '22.6457', 'groupId': 'OG001'}]}]}, {'title': 'CSF Phosphorylated Tau Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.266', 'spread': '1.8792', 'groupId': 'OG000'}, {'value': '11.231', 'spread': '1.8371', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.922', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.239', 'ciLowerLimit': '-62.020', 'ciUpperLimit': '68.498', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '32.8719', 'groupDescription': 'Cerebrospinal fluid Tau Protein Immunoassay', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.717', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.965', 'ciLowerLimit': '-6.241', 'ciUpperLimit': '4.311', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.6535', 'groupDescription': 'Cerebrospinal Fluid Phosphorylated Tau Protein Immunoassay', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'CSF concentrations of total tau and tau phosphorylated protein concentrations were analyzed using validated Immunoassay method. LS mean was derived using an analysis of covariance (ANCOVA) model with fixed effects of baseline CSF, treatment, APOE4 Carrier Status (yes/no) and age at baseline.', 'unitOfMeasure': 'nanograms per liter (ng/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have a baseline score and at least 1 post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Aβ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}], 'classes': [{'title': 'CSF Amyloid Beta 1-40 Modified ELISA - INNOTEST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12151.386', 'spread': '711.6120', 'groupId': 'OG000'}, {'value': '-587.063', 'spread': '691.2989', 'groupId': 'OG001'}]}]}, {'title': 'CSF Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1045.570', 'spread': '42.6843', 'groupId': 'OG000'}, {'value': '49.160', 'spread': '42.2627', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12738.449', 'ciLowerLimit': '10757.047', 'ciUpperLimit': '14719.851', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '998.7048', 'groupDescription': 'Cerebrospinal Fluid Amyloid Beta 1-40 Modified ELISA - INNOTEST', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '996.411', 'ciLowerLimit': '875.873', 'ciUpperLimit': '1116.948', 'pValueComment': 'p-value using ANCOVA model for endpoint measures: CHG = Baseline + APOE4 + AGE + Treatment.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '60.7404', 'groupDescription': 'Cerebrospinal Fluid Amyloid Beta 1-42 Mod Modified ELISA - INNOTEST', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'CSF biomarker concentrations were analyzed for Aβ 1-40 and Aβ 1-42 using Innotest Enzyme-linked immunosorbent assays (ELISA) method. LS mean was derived using an ANCOVA model with fixed effects of baseline CSF, treatment, APOE4 Carrier Status (yes/no) and age at baseline.', 'unitOfMeasure': 'nanograms per liter (ng/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have a baseline score and at least 1 post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '561', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.'}], 'classes': [{'title': 'Total hippocampal volume', 'categories': [{'measurements': [{'value': '-0.369', 'spread': '0.0276', 'groupId': 'OG000'}, {'value': '-0.314', 'spread': '0.0272', 'groupId': 'OG001'}]}]}, {'title': 'Total Lateral Ventricular Volume', 'categories': [{'measurements': [{'value': '9.329', 'spread': '0.3215', 'groupId': 'OG000'}, {'value': '8.978', 'spread': '0.3167', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.054', 'ciLowerLimit': '-0.131', 'ciUpperLimit': '0.022', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.0388', 'groupDescription': 'Total hippocampal volume', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.437', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.351', 'ciLowerLimit': '-0.535', 'ciUpperLimit': '1.236', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.4513', 'groupDescription': 'Total Lateral Ventricular Volume', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week approximately 240', 'description': "Alzheimer's disease is also associated with pronounced brain atrophy, reflecting bulk neurodegenerative loss of gray and white matter. Progression of brain atrophy is assessed by vMRI, providing regional quantification of volume loss. Negative change from baseline indicates greater disease severity. Total hippocampal volume and Total Lateral Ventricular Volume were analyzed for vMRI parameters. LS mean was derived using an ANCOVA model with fixed effects of baseline vMRI value, treatment, age at baseline, education, APOE4 Carrier Status (yes/no), and baseline florbetapir cortical SUVr.", 'unitOfMeasure': 'cubic centimeter (cm^3)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who have a baseline score and at least 1 post-baseline assessment.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Clinical Dementia Rating-Sum of Boxes Score (CDR-SB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}, {'id': 'OG001', 'title': 'Placebo/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}], 'timeFrame': 'Baseline, Week 336', 'description': 'The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18. Higher score indicates severe impairment.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Computerized Cognitive Composite (C3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Solanezumab/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}, {'id': 'OG001', 'title': 'Placebo/Solanezumab', 'description': 'Participants received 1600 mg solanezumab administered IV Q4W for 204 weeks (from week 240 to week 444) in open-label extension period.'}], 'timeFrame': 'Baseline, Week 336', 'description': 'The C3 includes tasks from the CogState battery aimed at measuring processing speed, working memory, visual navigation, and executive function. The C3 also include 2 investigator-developed sensitive episodic memory probes of hippocampal function. A composite score is generated and CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions.', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Delayed-start analyses were not conducted because no treatment difference was observed at the end of the placebo-controlled period. Hence, data were not evaluated for outcome measure analyses (week 336) in open-label extension period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Solanezumab/Solanezumab', 'description': 'Participants received 400 milligram (mg) solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered intravenously (IV) every 4 weeks (Q4W) for approximately 240 weeks in double-blind (placebo-controlled) period.\n\nParticipants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).'}, {'id': 'FG001', 'title': 'Placebo/Solanezumab', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.\n\nParticipants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).'}], 'periods': [{'title': 'Double-blind (Placebo Controlled) Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '578'}, {'groupId': 'FG001', 'numSubjects': '591'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '406'}, {'groupId': 'FG001', 'numSubjects': '424'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '167'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Coordinating Center Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Covid-19 Pandemic Disruption', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Investigator Recommendation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-Site Clinician Recommendation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Safety Risk', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Started Prohibited Medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Starting A New Treatment For Alzheimer's Disease", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Starting New Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Partner Unwilling Or Unable To Participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Family Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Subject Relocated to Another Place', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': "Subject's Expectation From Study Were not Aligned", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Personal Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discontinued Study due to Health Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Site Closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Medical Health of Study Partner', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'No Longer Wishes to Participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Subject Concurrently Enrolled in Another Clinical Drug Trial', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Starting Another Treatment for the Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': "Decision was Taken by Subject's Personal Doctor", 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Inability to have MRI due to Stimulator Implant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Open-label Extension Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Not all Participants who completed the Double-blind (Placebo Controlled) Period entered into Open-label Extension Period.', 'groupId': 'FG000', 'numSubjects': '383'}, {'comment': 'Not all Participants who completed the Double-blind (Placebo Controlled) Period entered into Open-label Extension Period.', 'groupId': 'FG001', 'numSubjects': '401'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '382'}, {'groupId': 'FG001', 'numSubjects': '400'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '313'}]}, {'type': 'Safety Risk', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Investigator Recommendation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Covid-19 Pandemic Disruption', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Coordinating Center Request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'No Longer Wishes to Participate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Study Ended', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'Personal Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Discontinued Study Due to Health Issues', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Travel Issues/Limitations', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Per protocol and statistical analysis plan (SAP), delayed-start analyses were not conducted because no treatment difference was observed at the end of the double-blind (placebo-controlled) period. Hence, data were not evaluated for outcome measure analyses (week 336), but safety data were analyzed for open-label extension period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Solanezumab/Solanezumab', 'description': 'Participants received 400 mg solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.\n\nParticipants begin open label extension and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).'}, {'id': 'BG001', 'title': 'Placebo/Solanezumab', 'description': 'Participants received placebo administered IV Q4W for approximately 240 weeks in double-blind (placebo-controlled) period.\n\nParticipants begin open label extension period and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71.9', 'spread': '4.6', 'groupId': 'BG000'}, {'value': '71.9', 'spread': '5.0', 'groupId': 'BG001'}, {'value': '71.9', 'spread': '4.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '337', 'groupId': 'BG000'}, {'value': '357', 'groupId': 'BG001'}, {'value': '694', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '241', 'groupId': 'BG000'}, {'value': '234', 'groupId': 'BG001'}, {'value': '475', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '556', 'groupId': 'BG000'}, {'value': '568', 'groupId': 'BG001'}, {'value': '1124', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '545', 'groupId': 'BG000'}, {'value': '555', 'groupId': 'BG001'}, {'value': '1100', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '497', 'groupId': 'BG000'}, {'value': '513', 'groupId': 'BG001'}, {'value': '1010', 'groupId': 'BG002'}]}]}, {'title': 'Japan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '578', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1169', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Preclinical Alzheimer Cognitive Composite (PACC) Total Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '572', 'groupId': 'BG000'}, {'value': '591', 'groupId': 'BG001'}, {'value': '1163', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '2.76', 'groupId': 'BG000'}, {'value': '0.01', 'spread': '2.60', 'groupId': 'BG001'}, {'value': '0.01', 'spread': '2.68', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-48 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: (ranges 0 \\[none\\]-135 \\[best performance\\]) and Mini Mental State Examination (Range 0 \\[worst\\] - 30 \\[best performance\\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'PACC z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement. Analysis population description included all randomized participants who had baseline PACC total score data.'}], 'populationDescription': 'All randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-08-09', 'size': 1996334, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-22T01:43', 'hasProtocol': True}, {'date': '2023-01-18', 'size': 1315158, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-22T01:44', 'hasProtocol': False}]}}, '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': 1169}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-14', 'studyFirstSubmitDate': '2013-12-06', 'resultsFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2013-12-06', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-14', 'studyFirstPostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \\[none\\]-91 \\[best performance\\]) and Mini Mental State Examination (Range 0 \\[worst\\] - 30 \\[best performance\\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.'}, {'measure': 'Change From Baseline of the Preclinical Alzheimer Cognitive Composite (PACC) Score', 'timeFrame': 'Baseline, Week 336', 'description': 'PACC has 4 components: Free and Cued Selective Reminding Test (0 (worst)-96 (best recall); Delayed Paragraph Recall test (Range 0 (worst)-25 (best recall); Wechsler Adult Intelligence scale: Digit Symbol Substitution Test (DSST): (ranges 0 \\[none\\]-91 \\[best performance\\]) and Mini Mental State Examination (Range 0 \\[worst\\] - 30 \\[best performance\\]). Component scores are transformed using an established normalization method into z-scores. Each of 4 component change scores is divided by baseline sample standard deviation (SD) of that component. These z scores are summed to form the composite score. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite. A z-score of 0 is equal to the mean and implies how many SD higher or lower score as compared with baseline score, with increase signifying improvement.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Cognitive Function Index (CFI)', 'timeFrame': 'Baseline, Week approximately 240', 'description': "The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and study partner/informant-reported outcome measure developed by the Alzheimer's Disease Cooperative Study (ADCS). This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A total score is calculated by combining participant-reported and an informant-reported scores, and ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment. LS mean was derived using natural cubic spline models with factors for treatment, time, and covariates = age, baseline florbetapir cortical SUVr score, years of education, APOE4 carrier status (n)."}, {'measure': 'Change From Baseline in Cognitive Function Index (CFI)', 'timeFrame': 'Baseline, Week 336', 'description': "The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument, a participant- and study partner/informant-reported outcome measure developed by the ADCS. This assessment includes 15 questions (14 of which contribute to the total score, and 1 additional unscored item) that assess the participant's perceived ability to perform high-level functional tasks in daily-life and sense of overall cognitive functional ability. Study participants and their informants independently rate the participant's abilities. A total score is calculated by combining participant-reported and an informant-reported scores, and ranges from 0 to 14 (yes=1; no=0; maybe=0.5 for each question) with higher scores indicating greater impairment."}, {'measure': "Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score", 'timeFrame': 'Baseline, Week approximately 240', 'description': 'The ADCS-ADL-prevention questionnaire is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant\'s level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don\'t know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment.'}, {'measure': "Change From Baseline in Alzheimer's Disease Cooperative Study-Activities Daily Living-Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score", 'timeFrame': 'Baseline, Week 336', 'description': 'The ADCS-ADL-prevention questionnaire is a functional measure composed of 18 items that includes 15 activities of daily living rated on a 4-point scale and 3 high level function items. Study participants and their informants independently rate the participant\'s level of ability (with no difficulty = 3, with some difficulty = 2, with a lot of difficulty = 1, did not do/don\'t know = 0). Informants are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if any errors were made performing the task. High-level function items are rated as "yes" or "no". The scores range from 0 to 45 with higher scores indicating less impairment. The total score is the sum of the scores of the 15 activities of daily living questions (range: 0-45) with higher scores indicating less impairment.'}, {'measure': 'Change From Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr)', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'Deposition of abnormal tau protein in the brain associated with AD was assessed by quantitative positron emission tomography (PET) scan using flortaucipir F-18. Flortaucipir is an F-18-labeled small molecule that binds with high affinity and selectivity to aggregated tau, and provides a measure of aggregated tau deposition in the brain, expressed as flortaucipir SUVr. LS Mean was calculated using an analysis of covariance (ANCOVA) model with fixed effects of baseline florbetapir result, treatment, APOE4 Carrier Status (yes/no), and age at baseline'}, {'measure': 'Change From Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'CSF concentrations of total tau and tau phosphorylated protein concentrations were analyzed using validated Immunoassay method. LS mean was derived using an analysis of covariance (ANCOVA) model with fixed effects of baseline CSF, treatment, APOE4 Carrier Status (yes/no) and age at baseline.'}, {'measure': 'Change From Baseline of Cerebrospinal Fluid (CSF) Concentrations of Amyloid Beta (Aβ)', 'timeFrame': 'Baseline, Week approximately 240', 'description': 'CSF biomarker concentrations were analyzed for Aβ 1-40 and Aβ 1-42 using Innotest Enzyme-linked immunosorbent assays (ELISA) method. LS mean was derived using an ANCOVA model with fixed effects of baseline CSF, treatment, APOE4 Carrier Status (yes/no) and age at baseline.'}, {'measure': 'Change From Baseline in Brain Volume as Measured by Volumetric Magnetic Resonance Imaging (vMRI)', 'timeFrame': 'Baseline, Week approximately 240', 'description': "Alzheimer's disease is also associated with pronounced brain atrophy, reflecting bulk neurodegenerative loss of gray and white matter. Progression of brain atrophy is assessed by vMRI, providing regional quantification of volume loss. Negative change from baseline indicates greater disease severity. Total hippocampal volume and Total Lateral Ventricular Volume were analyzed for vMRI parameters. LS mean was derived using an ANCOVA model with fixed effects of baseline vMRI value, treatment, age at baseline, education, APOE4 Carrier Status (yes/no), and baseline florbetapir cortical SUVr."}, {'measure': 'Change From Baseline on the Clinical Dementia Rating-Sum of Boxes Score (CDR-SB)', 'timeFrame': 'Baseline, Week 336', 'description': 'The CDR-SB is an interviewer administered scale and impairment is scored in each of categories: memory, orientation, judgment and problem solving, community affairs, home and hobbies and personal care. Impairment is scored on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2 and severe = 3. The 6 individual category ratings, or "box scores", were added together to give the CDR-Sum of Boxes which ranges from 0-18. Higher score indicates severe impairment.'}, {'measure': 'Change From Baseline on the Computerized Cognitive Composite (C3)', 'timeFrame': 'Baseline, Week 336', 'description': 'The C3 includes tasks from the CogState battery aimed at measuring processing speed, working memory, visual navigation, and executive function. The C3 also include 2 investigator-developed sensitive episodic memory probes of hippocampal function. A composite score is generated and CogState scores are measured on a linear scale (with no maximum score) and a reduction in scores compared to baseline indicates an improvement in cognitive functions.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cognition', 'Prevention'], 'conditions': ['Cognition Disorders']}, 'referencesModule': {'references': [{'pmid': '41085172', 'type': 'DERIVED', 'citation': 'Shirzadi Z, Schultz AP, Loghmani N, Yang HS, Ford J, Yaari R, Properzi M, Yau WW, Liu L, Rafii MS, Donohue MC, Brickman AM, Jack CR Jr, Greenberg SM, Aisen P, Sperling RA, Chhatwal JP; A4 Study Team. Independent effects of white matter lesion volume and APOE varepsilon4 on ARIA-H in A4 Study. Alzheimers Dement. 2025 Oct;21(10):e70751. doi: 10.1002/alz.70751.'}, {'pmid': '41001450', 'type': 'DERIVED', 'citation': "Digma LA, Young CB, Winer JR, Cody KA, Younes K, Sheng J, Insel PS, Rissman RA, Sperling R, Mormino EC. Continuum of Core 1 Biomarkers in Preclinical Alzheimer's Disease. medRxiv [Preprint]. 2025 Sep 19:2025.09.17.25336007. doi: 10.1101/2025.09.17.25336007."}, {'pmid': '40476544', 'type': 'DERIVED', 'citation': "Farina FR, Bennett M, Grill JD, Sperling R, Lawlor B, Griffith JW. Association of Alzheimer's disease concerns with amyloid burden and lifestyle behaviors in cognitively unimpaired older adults. Alzheimers Dement. 2025 Jun;21(6):e70225. doi: 10.1002/alz.70225."}, {'pmid': '40440591', 'type': 'DERIVED', 'citation': 'Dubbelman MA, Liu A, Donohue MC, Langford O, Raman R, Rentz DM, Amariglio R, Sperling RA, Aisen PS, Marshall GA; as the A4 Study team. Changes in Daily Functioning in Association With Tau and Amyloid Among Unimpaired Older Adults With and Without Elevated Amyloid. Neurology. 2025 Jun 24;104(12):e213775. doi: 10.1212/WNL.0000000000213775. Epub 2025 May 29.'}, {'pmid': '37458272', 'type': 'DERIVED', 'citation': "Sperling RA, Donohue MC, Raman R, Rafii MS, Johnson K, Masters CL, van Dyck CH, Iwatsubo T, Marshall GA, Yaari R, Mancini M, Holdridge KC, Case M, Sims JR, Aisen PS; A4 Study Team. Trial of Solanezumab in Preclinical Alzheimer's Disease. N Engl J Med. 2023 Sep 21;389(12):1096-1107. doi: 10.1056/NEJMoa2305032. Epub 2023 Jul 17."}, {'pmid': '35543002', 'type': 'DERIVED', 'citation': 'Lewis CK, Bernstein OM, Grill JD, Gillen DL, Sultzer DL. Anxiety and Depressive Symptoms and Cortical Amyloid-beta Burden in Cognitively Unimpaired Older Adults. J Prev Alzheimers Dis. 2022;9(2):286-296. doi: 10.14283/jpad.2022.13.'}, {'pmid': '35197359', 'type': 'DERIVED', 'citation': 'Grober E, Lipton RB, Sperling RA, Papp KV, Johnson KA, Rentz DM, Veroff AE, Aisen PS, Ezzati A. Associations of Stages of Objective Memory Impairment With Amyloid PET and Structural MRI: The A4 Study. Neurology. 2022 Mar 29;98(13):e1327-e1336. doi: 10.1212/WNL.0000000000200046. Epub 2022 Feb 23.'}], 'seeAlsoLinks': [{'url': 'https://trials.lillytrialguide.com/en-US/trial/4qngyPbBRKqiYWCI0ouGIQ', 'label': 'A Study of Solanezumab in Older Participants Who May be at Risk for Memory Loss (A4)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease \\[AD\\]).', 'detailedDescription': "The A4 study is a clinical trial for older individuals who have evidence of amyloid plaque build-up in their brains who may be at risk for memory loss and cognitive decline due to Alzheimer's disease. The A4 study will test an anti-amyloid investigational drug in older individuals who do not yet show symptoms of Alzheimer's disease cognitive impairment or dementia with the aim of slowing memory and cognitive decline. The A4 study will also test whether anti-amyloid treatment can delay the progression of AD related brain injury on imaging and other biomarkers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30\n* Has a global Clinical Dementia Rating (CDR) scale score at screening of 0\n* Has a Logical Memory II score at screening of 6 to 18\n* Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain amyloid pathology at screening\n* Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication)\n\nExclusion Criteria:\n\n* Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at screening or baseline\n* Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded\n* Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study\n* Has had a history within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness\n* Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of any in situ cancer that was appropriately treated and is being appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or in situ prostate cancer with normal prostate-specific antigen post-treatment\n* Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)\n* Is clinically judged by the investigator to be at serious risk for suicide\n* Has a history within the past 2 years of major depression or bipolar disorder as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM)\n* Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM\n\nOpen-Label Inclusion Criteria:\n\n* All participants who complete the placebo-controlled period will be allowed to continue into the open-label period"}, 'identificationModule': {'nctId': 'NCT02008357', 'acronym': 'A4', 'briefTitle': 'Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': "Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)", 'orgStudyIdInfo': {'id': '15275'}, 'secondaryIdInfos': [{'id': 'H8A-MC-LZAZ', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solanezumab/Solanezumab', 'description': 'Participants received 400 milligram (mg) solanezumab followed by 800 mg solanezumab and then 1600 milligram solanezumab administered intravenously (IV) every 4 weeks (Q4W) for approximately 240 weeks in double-blind placebo-controlled period.\n\nParticipants begin open label extension and received 1600 mg solanezumab Q4W for 204 weeks (from week 240 to week 444).', 'interventionNames': ['Drug: Solanezumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo/Solanezumab', 'description': 'Participants received placebo 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