Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2025-12-29 @ 7:25 PM
Study NCT ID:
NCT01955161
Status:
COMPLETED
Last Update Posted:
2017-09-19
First Post:
2013-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Sponsor:
Organization:
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': 'C568612', 'term': '(2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LundbeckClinicalTrials@lundbeck.com', 'phone': '+4536301311', 'title': 'Email contact via', 'organization': 'H. Lundbeck A/S'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline to end of study at Week 24', 'description': 'Treatment-Emergent Adverse Events are reported in this section', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil', 'otherNumAtRisk': 308, 'deathsNumAtRisk': 308, 'otherNumAffected': 39, 'seriousNumAtRisk': 308, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donezepil', 'otherNumAtRisk': 313, 'deathsNumAtRisk': 313, 'otherNumAffected': 56, 'seriousNumAtRisk': 313, 'deathsNumAffected': 1, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donezepil', 'otherNumAtRisk': 309, 'deathsNumAtRisk': 309, 'otherNumAffected': 49, 'seriousNumAtRisk': 309, 'deathsNumAffected': 3, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 19}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bacterial diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Radius fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastases to peritoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Dementia alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Impulse-control disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vaginal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 208, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colostomy closure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rehabilitation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 308, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 313, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 309, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Cognition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0.13', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.35', 'groupId': 'OG001'}, {'value': '0.18', 'spread': '0.35', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.9591', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.33', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '1.26', 'pValueComment': 'Corrected for multiplicity', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'estimateComment': 'A negative mean difference indicates a treatment effect in favour of idalopirdine', 'groupDescription': 'For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.98', 'pValueComment': 'Corrected for multiplicity according to the multiple testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'estimateComment': 'A negative mean difference indicates a treatment effect in favour of idalopirdine.', 'groupDescription': 'For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': "Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.\n\nThe Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}, {'type': 'SECONDARY', 'title': 'Change in Daily Functioning', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.03', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '-2.12', 'spread': '0.48', 'groupId': 'OG001'}, {'value': '-2.02', 'spread': '0.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-1.37', 'ciUpperLimit': '1.21', 'pValueComment': 'Corrected for multiplicity according toe the multiple testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'estimateComment': 'A positive mean difference indicates a treatment effect in favour of idalopirdine.', 'groupDescription': 'For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.01', 'ciLowerLimit': '-1.29', 'ciUpperLimit': '1.31', 'pValueComment': 'Corrected for multiplicity according to the multiple testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.66', 'estimateComment': 'A positive mean difference indicates a treatment effect in favour of idalopirdine.', 'groupDescription': 'For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': "Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.\n\nThe Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}, {'type': 'SECONDARY', 'title': 'Change in Global Impression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '303', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}, {'value': '307', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '4.29', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '4.32', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '4.13', 'spread': '0.07', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '1.000', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.15', 'ciUpperLimit': '0.20', 'pValueComment': 'Corrected for multiplicity according to the multiple testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'estimateComment': 'A negative mean difference indicates a treatment effect in favour of idalopirdine.', 'groupDescription': 'For demonstrating efficacy of a dose, change in cognition (ADAS-cog) and either change in daily functioning (ADCS-ADL23) or change in global clinical impression (ADCS-CGIC) had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions'}, {'pValue': '1.000', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.02', 'pValueComment': 'Corrected for multiplicity according to the multiple testing procedure', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.09', 'estimateComment': 'A negative mean difference indicates a treatment effect in favour of idalopirdine.', 'groupDescription': 'For demonstrating efficacy of a dose, ADAS-cog total score and either ADCS-ADL23 total score or ADCS CGIC had to show statistically significant favourable differences compared to placebo at Week 24. Multiple testing procedures were used to control the overall type 1 error at 5%. The null hypothesis of no difference in mean change from baseline in ADAS-cog total score at Week 24 was tested for each dose at significance level 2.5%.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Treatment, country, MMSE stratum, week as fixed effects, baseline score, treatment-by-week, MMSE stratum-by-week, and baseline-by-week interactions'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': "Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.\n\nThe Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}, {'type': 'SECONDARY', 'title': 'Change in Behavioural Disturbance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.21', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '-0.39', 'spread': '0.63', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score.\n\nThe Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 \\[occasionally\\] to 4 \\[very frequent\\]) and severity (a 3-point scale from 1 \\[mild\\] to 3 \\[marked\\]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}, {'type': 'SECONDARY', 'title': 'Change in Individual Behavioural Disturbance Items', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'title': 'Delusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.09', 'groupId': 'OG002'}]}]}, {'title': 'Hallucinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.07', 'groupId': 'OG001'}, {'value': '-0.03', 'spread': '0.07', 'groupId': 'OG002'}]}]}, {'title': 'Agitation/aggression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Depression/dysphoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.09', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.10', 'groupId': 'OG002'}]}]}, {'title': 'Anxiety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '-0.13', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Elation/euphoria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.05', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.05', 'groupId': 'OG002'}]}]}, {'title': 'Apathy/indifference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.18', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.23', 'spread': '0.15', 'groupId': 'OG001'}, {'value': '-0.27', 'spread': '0.15', 'groupId': 'OG002'}]}]}, {'title': 'Disinhibition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.08', 'groupId': 'OG000'}, {'value': '-0.06', 'spread': '0.08', 'groupId': 'OG001'}, {'value': '-0.01', 'spread': '0.08', 'groupId': 'OG002'}]}]}, {'title': 'Irritability/lability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.12', 'groupId': 'OG002'}]}]}, {'title': 'Aberrant motor behaviour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '0.33', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '0.13', 'groupId': 'OG002'}]}]}, {'title': 'Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '308', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.11', 'groupId': 'OG002'}]}]}, {'title': 'Appetite/eating disorder', 'denoms': [{'units': 'Participants', 'counts': [{'value': '304', 'groupId': 'OG000'}, {'value': '310', 'groupId': 'OG001'}, {'value': '308', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.08', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '-0.04', 'spread': '0.13', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Change in single NPI item scores at Week 24.\n\nThe Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 \\[occasionally\\] to 4 \\[very frequent\\]) and severity (a 3-point scale from 1 \\[mild\\] to 3 \\[marked\\]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure/item assessed'}, {'type': 'SECONDARY', 'title': 'Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.12', 'spread': '0.30', 'groupId': 'OG000'}, {'value': '-1.56', 'spread': '0.30', 'groupId': 'OG001'}, {'value': '-1.64', 'spread': '0.32', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline\n\nThe Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 \\[occasionally\\] to 4 \\[very frequent\\]) and severity (a 3-point scale from 1 \\[mild\\] to 3 \\[marked\\]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome/item measure assessed'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \\[change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4\\])', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}, {'type': 'SECONDARY', 'title': 'Clinical Worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '290', 'groupId': 'OG001'}, {'value': '278', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24', 'description': 'Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \\[change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4\\])', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Aspects of Mental Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'spread': '0.16', 'groupId': 'OG000'}, {'value': '-0.27', 'spread': '0.16', 'groupId': 'OG001'}, {'value': '0.27', 'spread': '0.17', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}, {'type': 'SECONDARY', 'title': 'Change in Health-related Quality of Life (EQ-5D) Utility Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.01', 'spread': '0.01', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.01', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.01', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': "Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score\n\nThe EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}, {'type': 'SECONDARY', 'title': 'Change in Health-related Quality of Life (EQ-5D VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '301', 'groupId': 'OG000'}, {'value': '307', 'groupId': 'OG001'}, {'value': '304', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'OG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'OG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '1.01', 'groupId': 'OG001'}, {'value': '0.34', 'spread': '1.03', 'groupId': 'OG002'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24', 'description': "Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).\n\nThe EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who took at least one dose of placebo or idalopirdine, and who had a valid baseline assessment and at least on valid post-baseline assessment of the primary outcome measure in the 24-week treatment period (Full-analysis Set). For secondary outcome measures, the number of participants who had the respective outcome measure assessed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'FG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'FG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '310'}, {'groupId': 'FG001', 'numSubjects': '313'}, {'groupId': 'FG002', 'numSubjects': '310'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '308'}, {'groupId': 'FG001', 'numSubjects': '313'}, {'groupId': 'FG002', 'numSubjects': '309'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '283'}, {'groupId': 'FG001', 'numSubjects': '288'}, {'groupId': 'FG002', 'numSubjects': '275'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '35'}]}], 'dropWithdraws': [{'type': 'Withdrawal before treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '12'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other reason: physician decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other reason: disallowed medication', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other reason: caregiver unavailable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other reason: moved to nursing home', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other reason: insufficient compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other reason: primary biliary cirrhosis', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': "Other reason: patient's will", 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '308', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '309', 'groupId': 'BG002'}, {'value': '930', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil\n\nPlacebo: Once daily, matching placebo capsules, orally'}, {'id': 'BG001', 'title': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'BG002', 'title': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil\n\nIdalopirdine: Once daily, encapsulated tablets, orally'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.8', 'spread': '8.0', 'groupId': 'BG000'}, {'value': '74.0', 'spread': '8.8', 'groupId': 'BG001'}, {'value': '73.7', 'spread': '8.6', 'groupId': 'BG002'}, {'value': '73.8', 'spread': '8.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '208', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '607', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '323', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}, {'value': '125', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '266', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '267', 'groupId': 'BG002'}, {'value': '801', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': 'NA', 'comment': 'Information has not been collected', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Information has not been collected', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Information has not been collected', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '283', 'groupId': 'BG000'}, {'value': '287', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}, {'value': '854', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': 'NA', 'comment': 'Information has not been collected', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Information has not been collected', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Information has not been collected', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Argentina', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '109', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '130', 'groupId': 'BG003'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'MMSE total score at screening', 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '17.2', 'spread': '3.1', 'groupId': 'BG001'}, {'value': '17.4', 'spread': '2.9', 'groupId': 'BG002'}, {'value': '17.4', 'spread': '3.0', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'A total of 933 patients were randomized into the study but 3 patients were not treated (did not receive IMP). The baseline analysis population only consist of patients who have been treated.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 933}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2013-09-27', 'resultsFirstSubmitDate': '2017-07-11', 'studyFirstSubmitQcDate': '2013-09-27', 'lastUpdatePostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-08-22', 'studyFirstPostDateStruct': {'date': '2013-10-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Cognition', 'timeFrame': 'Baseline to Week 24', 'description': "Change from baseline to Week 24 in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) total score.\n\nThe Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) is a 11-item neuropsychological test that assess the severity of cognitive impairment. The items determine the patient's orientation, memory, language, and praxis. Total score of the 11 items range from 0 to 70 (lower score indicates lower cognitive impairment)."}], 'secondaryOutcomes': [{'measure': 'Change in Daily Functioning', 'timeFrame': 'Baseline to Week 24', 'description': "Change from baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL23) total score.\n\nThe Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL23) is a 23-item clinician-rated inventory to assess activities of daily living (conducted with a caregiver or informant). Each item comprises a series of hierarchical sub-questions, ranging from the highest level of independent performance to a complete loss for each activity. Total score of the 23 items ranges from 0 to 78 (higher score indicates lower disability)."}, {'measure': 'Change in Global Impression', 'timeFrame': 'Baseline to Week 24', 'description': "Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) score at Week 24.\n\nThe Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change is a semi-structured interview to assess clinically relevant changes in patients with AD. The items determine cognition, behavior, social and daily functioning. Severity at baseline is rated on a 7-point scale from 1 (normal, not ill at all) to 7 (among the most extremely ill patients). The clinically relevant change from baseline is rated on a 7-point scale from 1 (marked improvement) to 7 (marked worsening)."}, {'measure': 'Change in Behavioural Disturbance', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline to Week 24 in Neuropsychiatric Inventory (NPI) total score.\n\nThe Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is rated for frequency (a 4-point scale from 1 \\[occasionally\\] to 4 \\[very frequent\\]) and severity (a 3-point scale from 1 \\[mild\\] to 3 \\[marked\\]). The total NPI score is the frequency ratings multiplied by the severity ratings and ranges from 0 to 144 (higher score indicates worse outcome).'}, {'measure': 'Change in Individual Behavioural Disturbance Items', 'timeFrame': 'Baseline to Week 24', 'description': 'Change in single NPI item scores at Week 24.\n\nThe Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 \\[occasionally\\] to 4 \\[very frequent\\]) and severity (a 3-point scale from 1 \\[mild\\] to 3 \\[marked\\]). Total score for each single NPI item ranges from 0-12 (frequency multiplied by severity), where higher scores represent worse outcome.'}, {'measure': 'Change in NPI Anxiety Item Score in Patients With an NPI Anxiety Item Score of at Least 2 at Baseline', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline to Week 24 in NPI anxiety item score in patients with an NPI anxiety item score of at least 2 at baseline\n\nThe Neuropsychiatric Inventory is a 12-item structured interview with a caregiver to assess behavioural disturbances. The NPI comprises 10 behavioural and 2 neurovegetative items. Each item consists of a screening question and several sub-questions that are rated no (not present) or yes (present). Each item is then rated for frequency (a 4-point scale from 1 \\[occasionally\\] to 4 \\[very frequent\\]) and severity (a 3-point scale from 1 \\[mild\\] to 3 \\[marked\\]). The total score for the NPI anxiety item ranges from 0-12 (frequency multiplied by severity), where a higher score represents a worse outcome.'}, {'measure': 'Clinical Improvement', 'timeFrame': 'Week 24', 'description': 'Clinical response at Week 24 (based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \\[change in ADAS-cog below or equal to -4, change in ADCS-ADL23 at least 0, and ADCS-CGIC below or equal to 4\\])'}, {'measure': 'Clinical Worsening', 'timeFrame': 'Week 24', 'description': 'Clinical worsening at Week 24 (Based on pre-specified ADAS-cog, ADCS-ADL23, and ADCS-CGIC changes \\[change in ADAS-cog above or equal to 4, change in ADCS-ADL23 below 0, and ADCS-CGIC above 4\\])'}, {'measure': 'Change in Cognitive Aspects of Mental Function', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline to Week 24 in Mini Mental State Examination (MMSE). The Mini Mental State Examination (MMSE) is an 11-item test to assess the cognitive aspects of mental function. The subtests assess orientation, memory, attention, language, and visual construction. The scores for each item is dichotomous (1 = response is correct, 0 = response is incorrect). Total score of the 11 items ranges from 0 to 30 (higher score indicates lower deficit).'}, {'measure': 'Change in Health-related Quality of Life (EQ-5D) Utility Score', 'timeFrame': 'Baseline to Week 24', 'description': "Change from baseline to Week 24 in EuroQol 5-dimensional (EQ-5D) utility score\n\nThe EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). Each descriptive item is rated on a 3-point index ranging from 1 (no problems) to 3 (extreme problems) that is used for calculating a single summary index (from 0 to 1). A higher EQ-5D score indicates a worse outcome."}, {'measure': 'Change in Health-related Quality of Life (EQ-5D VAS)', 'timeFrame': 'Baseline to Week 24', 'description': "Change from baseline to Week 24 in EQ-5D Visual Analogue Scale (EQ-5D VAS).\n\nThe EQ-5D is a patient-reported assessment that measures the patient's well-being. It consists of an utility score based on 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a Visual Analogue Scale (VAS). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state)."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '31193334', 'type': 'DERIVED', 'citation': "Ballard C, Atri A, Boneva N, Cummings JL, Frolich L, Molinuevo JL, Tariot PN, Raket LL. Enrichment factors for clinical trials in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2019 May 20;5:164-174. doi: 10.1016/j.trci.2019.04.001. eCollection 2019."}, {'pmid': '30474567', 'type': 'DERIVED', 'citation': "Cummings JL, Atri A, Ballard C, Boneva N, Frolich L, Molinuevo JL, Raket LL, Tariot PN. Insights into globalization: comparison of patient characteristics and disease progression among geographic regions in a multinational Alzheimer's disease clinical program. Alzheimers Res Ther. 2018 Nov 24;10(1):116. doi: 10.1186/s13195-018-0443-2."}, {'pmid': '29318278', 'type': 'DERIVED', 'citation': 'Atri A, Frolich L, Ballard C, Tariot PN, Molinuevo JL, Boneva N, Windfeld K, Raket LL, Cummings JL. Effect of Idalopirdine as Adjunct to Cholinesterase Inhibitors on Change in Cognition in Patients With Alzheimer Disease: Three Randomized Clinical Trials. JAMA. 2018 Jan 9;319(2):130-142. doi: 10.1001/jama.2017.20373.'}]}, 'descriptionModule': {'briefSummary': "To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic treatment of patients with mild-to-moderate Alzheimer's disease (AD).", 'detailedDescription': 'The study consisted of a screening period (up to 2-week period from screening to randomization), a 24-week double-blind treatment period with placebo or idalopirdine 30 mg/day or 60 mg/day as adjunctive therapy to donepezil 10 mg/day, and a 4-week safety follow-up period following study completion or withdrawal from treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patient has a knowledgeable and reliable caregiver.\n* The patient is an outpatient.\n* The patient has probable AD.\n* The patient has mild to moderate AD.\n* Stable treatment with donepezil.\n* The patient, if a woman, must have had her last natural menstruation ≥24 months prior to baseline, OR be surgically sterile.\n* The patient, if a man, agrees to protocol-defined use of effective contraception if his female partner is of childbearing potential, OR must have been surgically sterilised prior to the screening visit.\n\nExclusion Criteria:\n\n* The patient has evidence of any clinically significant neurodegenerative disease, or other serious neurological disorders other than AD.\n* The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) Axis I disorder other than AD.\n* The patient has evidence of clinically significant disease.\n* The patient's donepezil therapy is likely to be interrupted or discontinued during the study.\n* The patient is currently receiving memantine or has taken memantine within 2 months prior to screening.\n\nOther inclusion and exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT01955161', 'acronym': 'STARSHINE', 'briefTitle': "Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil", 'organization': {'class': 'INDUSTRY', 'fullName': 'H. Lundbeck A/S'}, 'officialTitle': "Randomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil", 'orgStudyIdInfo': {'id': '14861A'}, 'secondaryIdInfos': [{'id': '2012-004763-45', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo adjunct to 10 mg Donepezil', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Idalopirdine 30 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil', 'interventionNames': ['Drug: Idalopirdine']}, {'type': 'EXPERIMENTAL', 'label': 'Idalopirdine 60 mg', 'description': 'Idalopirdine adjunct to 10 mg Donepezil', 'interventionNames': ['Drug: Idalopirdine']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Once daily, matching placebo capsules, orally', 'armGroupLabels': ['Placebo']}, {'name': 'Idalopirdine', 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