Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-02-13 @ 10:52 AM
Study NCT ID:
NCT02580305
Status:
COMPLETED
Last Update Posted:
2023-06-09
First Post:
2015-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
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': 'C000621657', 'term': '1-((2-bromophenyl)sulfonyl)-5-methoxy-3-((4-methyl-1-piperazinyl)methyl)-1H-indole dimesylate monohydrate'}, {'id': 'D000077265', 'term': 'Donepezil'}, {'id': 'C000610194', 'term': 'Namzaric'}, {'id': 'D008559', 'term': 'Memantine'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nvsrk@suven.com', 'phone': '+9140 2319 3956', 'title': 'Ramakrishna Nirogi, PhD', 'organization': 'Suven Life Sciences'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '26 Weeks', 'description': 'Safety population is considered for reporting total number of participants at risk.', 'eventGroups': [{'id': 'EG000', 'title': 'SUVN-502 Low Dose (50 mg)', 'description': 'SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine', 'otherNumAtRisk': 187, 'deathsNumAtRisk': 187, 'otherNumAffected': 50, 'seriousNumAtRisk': 187, 'deathsNumAffected': 3, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'SUVN-502 High Dose (100 mg)', 'description': 'SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine', 'otherNumAtRisk': 181, 'deathsNumAtRisk': 181, 'otherNumAffected': 44, 'seriousNumAtRisk': 181, 'deathsNumAffected': 2, 'seriousNumAffected': 14}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo adjunct to base treatment with Donepezil and Memantine', 'otherNumAtRisk': 188, 'deathsNumAtRisk': 188, 'otherNumAffected': 40, 'seriousNumAtRisk': 188, 'deathsNumAffected': 1, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 26, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 22, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 16, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Diaphragmatic hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Incarcerated inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Bladder transitional cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Malignant neoplasm of unknown primary site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Bile duct obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 187, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 188, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 18.1.'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SUVN-502 Low Dose (50 mg)', 'description': 'SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG001', 'title': 'SUVN-502 High Dose (100 mg)', 'description': 'SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo adjunct to base treatment with Donepezil and Memantine'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '2.6', 'spread': '0.5', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.41', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}, {'pValue': '0.90', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 26', 'description': 'Mean change from baseline at week 26 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The scale ranges from 0 to 70, with higher scores indicate greater impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat (mITT) population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SUVN-502 Low Dose (50 mg)', 'description': 'SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG001', 'title': 'SUVN-502 High Dose (100 mg)', 'description': 'SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo adjunct to base treatment with Donepezil and Memantine'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.2', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}, {'pValue': '0.48', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 26', 'description': "Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.\n\nSeverity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat (mITT) population'}, {'type': 'SECONDARY', 'title': "Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SUVN-502 Low Dose (50 mg)', 'description': 'SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG001', 'title': 'SUVN-502 High Dose (100 mg)', 'description': 'SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo adjunct to base treatment with Donepezil and Memantine'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-3.4', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '-4.4', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.83', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}, {'pValue': '0.24', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 26', 'description': "The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.\n\nThe ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat (mITT) population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SUVN-502 Low Dose (50 mg)', 'description': 'SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG001', 'title': 'SUVN-502 High Dose (100 mg)', 'description': 'SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo adjunct to base treatment with Donepezil and Memantine'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '2.1', 'spread': '0.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.17', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}, {'pValue': '0.14', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 26', 'description': 'Neuropsychiatric Inventory (NPI) 12 item - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.\n\nTotal score ranges from 12 to 144; higher scores indicate greater disease severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat (mITT) population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'OG000'}, {'value': '176', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SUVN-502 Low Dose (50 mg)', 'description': 'SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG001', 'title': 'SUVN-502 High Dose (100 mg)', 'description': 'SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo adjunct to base treatment with Donepezil and Memantine'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '-1.0', 'spread': '0.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}, {'pValue': '0.92', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'Threshold for statistical significance was p≤0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 26', 'description': 'Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0, Maximum Score - 30. Higher score means better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'modified intent to treat (mITT) population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SUVN-502 Low Dose (50 mg)', 'description': 'SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'FG001', 'title': 'SUVN-502 High Dose (100 mg)', 'description': 'SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo adjunct to base treatment with Donepezil and Memantine'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '190'}, {'groupId': 'FG001', 'numSubjects': '185'}, {'groupId': 'FG002', 'numSubjects': '189'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '187'}, {'groupId': 'FG001', 'numSubjects': '181'}, {'groupId': 'FG002', 'numSubjects': '188'}]}, {'type': 'Modified Intent-to-treat (mITT) Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '184'}, {'groupId': 'FG001', 'numSubjects': '176'}, {'groupId': 'FG002', 'numSubjects': '183'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}, {'groupId': 'FG001', 'numSubjects': '136'}, {'groupId': 'FG002', 'numSubjects': '157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '49'}, {'groupId': 'FG002', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Randomized in error and never treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'recruitmentDetails': 'Study centers located in the United States of America (USA) participated in the study'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '176', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}, {'value': '543', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'SUVN-502 Low Dose (50 mg)', 'description': 'SUVN-502 Low dose (50 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'BG001', 'title': 'SUVN-502 High Dose (100 mg)', 'description': 'SUVN-502 High dose (100 mg) adjunct to base treatment with Donepezil and Memantine'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo adjunct to base treatment with Donepezil and Memantine'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '73.4', 'spread': '8.08', 'groupId': 'BG000'}, {'value': '74.4', 'spread': '6.97', 'groupId': 'BG001'}, {'value': '72.9', 'spread': '7.23', 'groupId': 'BG002'}, {'value': '73.6', 'spread': '7.46', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age group greater than or equal to 65 years', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '155', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '471', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '297', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '246', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '168', 'groupId': 'BG002'}, {'value': '501', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'APO-E4 Carrier Status', 'classes': [{'title': 'Carrier one allele', 'categories': [{'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}]}, {'title': 'Carrier two allele', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mini-Mental State Examination', 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'spread': '2.21', 'groupId': 'BG000'}, {'value': '17.0', 'spread': '2.47', 'groupId': 'BG001'}, {'value': '16.5', 'spread': '2.48', 'groupId': 'BG002'}, {'value': '16.8', 'spread': '2.39', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Mini-Mental State Examination (MMSE) was used to measure cognitive impairment. The MMSE can evaluate overall cognitive function, and is widely used for the assessment of cognitive impairment in dementia patients. The questionnaire consists of 11 items, and each item aims to evaluate different cognitive domains such as orientation, memory, attention, and construction. The score ranged from 0 to 30, with a higher score indicating better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'A total of 564 patients were randomized as per the planned ratio to receive masupirdine 50 mg (190 patients), masupirdine 100 mg (185 patients), or placebo (189 patients). A total of 543 (96.3%) patients who were randomized to specific treatment sequence were included in the modified intent to treat (mITT) population and this mITT population is considered for baseline analysis.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-03-02', 'size': 30310264, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-04-17T07:22', 'hasProtocol': True}, {'date': '2019-10-31', 'size': 15571880, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-04-17T07:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 564}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'dispFirstSubmitDate': '2020-11-03', 'completionDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2015-10-17', 'dispFirstSubmitQcDate': '2020-11-03', 'resultsFirstSubmitDate': '2023-04-17', 'studyFirstSubmitQcDate': '2015-10-17', 'dispFirstPostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-16', 'studyFirstPostDateStruct': {'date': '2015-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline to Week-26 in Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)", 'timeFrame': 'Baseline to Week 26', 'description': 'Mean change from baseline at week 26 is assessed for ADAS-Cog11 score. The ADAS-Cog11 is a structured scale that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. ADAS-Cog11 measures cognition by assessing 11 metrics impaired in AD: word recall; commands; constructional praxis; naming objects and fingers; ideational praxis; orientation; word recognition; remembering test instructions; spoken language ability; word-finding difficulty; and comprehension of spoken language. The scale ranges from 0 to 70, with higher scores indicate greater impairment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week-26 in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)', 'timeFrame': 'Baseline to Week 26', 'description': "Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care.\n\nSeverity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity."}, {'measure': "Change From Baseline to Week-26 in Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)", 'timeFrame': 'Baseline to Week 26', 'description': "The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.\n\nThe ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity."}, {'measure': 'Change From Baseline to Week-26 in Neuropsychiatric Inventory (NPI)', 'timeFrame': 'Baseline to Week 26', 'description': 'Neuropsychiatric Inventory (NPI) 12 item - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.\n\nTotal score ranges from 12 to 144; higher scores indicate greater disease severity.'}, {'measure': 'Change From Baseline to Week-26 in Change in Mini Mental State Examination (MMSE)', 'timeFrame': 'Baseline to Week 26', 'description': 'Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0, Maximum Score - 30. Higher score means better outcome.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SUVN-502', '5-HT6', 'Phase 2', 'Cognition', 'Donepezil', 'Memantine', "Alzheimer's Disease", 'Triple Combination', 'Proof of Concept (POC)'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '36168659', 'type': 'RESULT', 'citation': "Nirogi R, Jayarajan P, Benade V, Shinde A, Goyal VK, Jetta S, Ravula J, Abraham R, Grandhi VR, Subramanian R, Pandey SK, Badange RK, Mohammed AR, Jasti V, Ballard C, Cummings J. Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses. Int J Geriatr Psychiatry. 2022 Oct;37(10):10.1002/gps.5813. doi: 10.1002/gps.5813."}, {'pmid': '35662833', 'type': 'RESULT', 'citation': "Nirogi R, Ieni J, Goyal VK, Ravula J, Jetta S, Shinde A, Jayarajan P, Benade V, Palacharla VRC, Dogiparti DK, Jasti V, Atri A, Cummings J. Effect of masupirdine (SUVN-502) on cognition in patients with moderate Alzheimer's disease: A randomized, double-blind, phase 2, proof-of-concept study. Alzheimers Dement (N Y). 2022 Jun 1;8(1):e12307. doi: 10.1002/trc2.12307. eCollection 2022."}, {'pmid': '35908254', 'type': 'RESULT', 'citation': 'Nirogi R, Goyal VK, Benade V, Subramanian R, Ravula J, Jetta S, Shinde A, Pandey SK, Jayarajan P, Jasti V, Cummings J. Effect of Concurrent Use of Memantine on the Efficacy of Masupirdine (SUVN-502): A Post Hoc Analysis of a Phase 2 Randomized Placebo-Controlled Study. Neurol Ther. 2022 Dec;11(4):1583-1594. doi: 10.1007/s40120-022-00390-4. Epub 2022 Jul 31.'}], 'seeAlsoLinks': [{'url': 'https://doi.org/10.18103/mra.v10i9.3061', 'label': "Effect of Age, Cognitive Impairment Severity, and Duration of Disease on Efficacy of Masupirdine in Moderate Alzheimer's Disease Patients: A Post Hoc Analysis of a Phase-2 Randomized Placebo Controlled Study Results"}]}, 'descriptionModule': {'briefSummary': "This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable doses of donepezil HCl and memantine HCl.", 'detailedDescription': "This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving donepezil HCl (10 mg qd) and either memantine HCl (10 mg twice daily \\[bid\\]) or Namenda XR® (Extended Release, 28 mg qd) or the combination therapy, Namzaric™\n\nThe primary objective of the study is to evaluate the efficacy of a serotonin receptor subtype 6 (5-HT6) antagonist, SUVN-502, compared to placebo, as adjunct treatment in subjects with moderate Alzheimer's disease (Mini-Mental State Examination \\[MMSE\\] score of 12 to 20) currently treated with the acetylcholinesterase inhibitor, donepezil hydrochloride (HCl), and the N-methyl-D-aspartic acid (NMDA) antagonist, memantine HCl. Efficacy will be assessed by the 11-item Alzheimer's Disease Assessment Scale for Cognitive Behavior (ADAScog-11) after 26 weeks of treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has a diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 1 year prior to the screening visit.\n* Has a score between 12 and 20 inclusive on the MMSE at the screening and baseline visits.\n* Has a MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies.\n* Must be receiving treatment with stable doses of donepezil HCl and memantine HCl for at least 3 months prior to the screening visit\n* Availability of an eligible and reliable caregiver\n* Must be living in the community or an assisted living facility.\n* Must be ambulatory or ambulatory aided (use of cane or walker).\n* Is not pregnant or planning to become pregnant during the study.\n* Subject (or subject's legally acceptable representative) and caregiver must sign an Informed Consent to participate in the study.\n\nExclusion Criteria:\n\n* Has a diagnosis of dementia due to other than Alzheimer's Disease\n* Is taking cholinesterase inhibitors other than donepezil HCl or taking doses of donepezil HCl other than 10 mg\n* Is taking doses of memantine HCl other than 10 mg bid or Namenda XR® 28 mg qd.\n* Has uncontrolled cardiac disease or hypertension.\n* Has clinically significant renal or hepatic impairment.\n* Has cancer or a malignant tumor, untreated thyroid disorder or has a history of seizure disorder\n* Is treated or likely to require treatment during the study, with any medications prohibited by the study protocol."}, 'identificationModule': {'nctId': 'NCT02580305', 'briefTitle': "SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Suven Life Sciences Limited'}, 'officialTitle': "A Phase 2a Multicenter, Randomized, Double-Blind, Parallel Group, 26-Week, Placebo-Controlled Study of SUVN-502 in Subjects With Moderate Alzheimer's Disease Currently Treated With Donepezil Hydrochloride and Memantine Hydrochloride", 'orgStudyIdInfo': {'id': 'CTP2S1502HT6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental: SUVN-502 Low dose (50 mg)', 'description': 'SUVN-502 Low dose adjunct to base treatment with Donepezil and Memantine', 'interventionNames': ['Drug: SUVN-502', 'Drug: Donepezil', 'Drug: Memantine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental: SUVN-502 High dose (100 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