Viewing Study NCT02669433

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Ignite Creation Date: 2025-12-25 @ 3:05 AM
Ignite Modification Date: 2026-02-25 @ 7:04 PM
Study NCT ID: NCT02669433
Status: COMPLETED
Last Update Posted: 2019-04-26
First Post: 2016-01-25
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C548140', 'term': '3-benzenesulfonyl-8-piperazin-1-ylquinoline'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ilise.lombardo@axovant.com', 'phone': '646-822-8626', 'title': 'Ilise Lombardo, MD', 'organization': 'Axovant Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'All proposed manuscripts, publications or abstracts must be reviewed and approved by the Sponsor 60 days prior to submission for publication. All confidential information identified by the Sponsor must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Screening through post treatment (up to 33 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo: once daily, oral, matching tablets', 'otherNumAtRisk': 91, 'deathsNumAtRisk': 91, 'otherNumAffected': 66, 'seriousNumAtRisk': 91, 'deathsNumAffected': 1, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'RVT-101 35 mg', 'description': 'RVT-101 35 mg once daily\n\nRVT-101 35 mg: once daily, oral, 35-mg tablets', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 69, 'seriousNumAtRisk': 89, 'deathsNumAffected': 1, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'RVT-101 70 mg', 'description': 'RVT-101 70 mg once daily\n\nRVT-101 70 mg: once daily, oral, 35-mg tablets', 'otherNumAtRisk': 88, 'deathsNumAtRisk': 88, 'otherNumAffected': 59, 'seriousNumAtRisk': 88, 'deathsNumAffected': 2, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 18}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nasopharygitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'seriousEvents': [{'term': 'Deep vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Trifascicular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Haemorrhagic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hallucination, visual', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Mental status change', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Neuropsychiatric syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Volvulus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Cholecystitiis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 91, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 89, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 88, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects dosed with two Placebo tablets\n\nPlacebo: once daily, oral, matching tablets'}, {'id': 'OG001', 'title': 'RVT-101 35 mg', 'description': 'Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101\n\nRVT-101 35 mg: once daily, oral, 35-mg tablets'}, {'id': 'OG002', 'title': 'RVT-101 70 mg', 'description': 'Subjects dosed with two RVT-101 35 mg tablets\n\nRVT-101 70 mg: once daily, oral, 35-mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.55', 'spread': '1.039', 'groupId': 'OG000'}, {'value': '1.45', 'spread': '1.025', 'groupId': 'OG001'}, {'value': '-1.29', 'spread': '1.056', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.158', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.01', 'ciLowerLimit': '-4.80', 'ciUpperLimit': '0.79', 'pValueComment': 'The threshold for statistical significance was p=0.05', 'estimateComment': 'Placebo - active', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6069', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.74', 'ciLowerLimit': '-2.08', 'ciUpperLimit': '3.55', 'pValueComment': 'The threshold for statistical significance was p=0.05', 'estimateComment': 'Placebo - active', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'UPDRS Primary Population'}, {'type': 'SECONDARY', 'title': "Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects dosed with two Placebo tablets\n\nPlacebo: once daily, oral, matching tablets'}, {'id': 'OG001', 'title': 'RVT-101 35 mg', 'description': 'Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101\n\nRVT-101 35 mg: once daily, oral, 35-mg tablets'}, {'id': 'OG002', 'title': 'RVT-101 70 mg', 'description': 'Subjects dosed with two RVT-101 35 mg tablets\n\nRVT-101 70 mg: once daily, oral, 35-mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '1.68', 'spread': '0.774', 'groupId': 'OG000'}, {'value': '2.15', 'spread': '0.769', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '0.796', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.6531', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-2.55', 'ciUpperLimit': '1.60', 'estimateComment': 'Placebo - active', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5274', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.67', 'ciLowerLimit': '-1.41', 'ciUpperLimit': '2.75', 'pValueComment': 'The threshold for statistical significance was p=0.05', 'estimateComment': 'Placebo - active', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': "Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24", 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects dosed with two Placebo tablets\n\nPlacebo: once daily, oral, matching tablets'}, {'id': 'OG001', 'title': 'RVT-101 35 mg', 'description': 'Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101\n\nRVT-101 35 mg: once daily, oral, 35-mg tablets'}, {'id': 'OG002', 'title': 'RVT-101 70 mg', 'description': 'Subjects dosed with two RVT-101 35 mg tablets\n\nRVT-101 70 mg: once daily, oral, 35-mg tablets'}], 'classes': [{'categories': [{'measurements': [{'value': '4.42', 'spread': '0.127', 'groupId': 'OG000'}, {'value': '4.27', 'spread': '0.128', 'groupId': 'OG001'}, {'value': '4.35', 'spread': '0.131', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3953', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.2', 'ciUpperLimit': '0.5', 'pValueComment': 'The threshold for statistical significance was p=0.05', 'estimateComment': 'Placebo - active', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7008', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '0.42', 'pValueComment': 'The threshold for statistical significance was p=0.05', 'estimateComment': 'Placebo - active', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change from Baseline at 24 weeks', 'description': "To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects dosed with two Placebo tablets\n\nPlacebo: once daily, oral, matching tablets'}, {'id': 'FG001', 'title': 'RVT-101 35 mg', 'description': 'Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101\n\nRVT-101 35 mg: once daily, oral, 35-mg tablets'}, {'id': 'FG002', 'title': 'RVT-101 70 mg', 'description': 'Subjects dosed with two RVT-101 35 mg tablets\n\nRVT-101 70 mg: once daily, oral, 35-mg tablets'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '89'}]}, {'type': 'Safety Population', 'comment': 'The Safety population included subjects who took at least 1 dose of double-blind study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '91'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '88'}]}, {'type': 'Intent to Treat (ITT) Population', 'comment': 'Subjects took at least 1 dose of double-blind study drug and had at least 1 post-baseline assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '87'}]}, {'type': 'Per-Protocol Population', 'comment': 'Subjects in the ITT population who had no major protocol violations', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '79'}, {'groupId': 'FG002', 'numSubjects': '82'}]}, {'type': 'Completers Population', 'comment': 'Subjects in the ITT population who completed the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '72'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'UPDRS Primary Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '87'}, {'groupId': 'FG002', 'numSubjects': '84'}]}, {'type': 'COMPLETED', 'comment': 'Subjects who completed every visit per protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Disease Progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Sponsor Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Caregiver', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '484 participants signed consent and were screened for participation. Of these, 306 entered a 2-week single-blind placebo run-in period with treatment with placebo qd. There was an overlap between the participants from the run-in period and the participants that were randomized during the treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects dosed with two Placebo tablets\n\nPlacebo: once daily, oral, matching tablets'}, {'id': 'BG001', 'title': 'RVT-101 35 mg', 'description': 'Subjects dosed with one Placebo tablet + 1 35 mg tablet of RVT-101\n\nRVT-101 35 mg: once daily, oral, 35-mg tablets'}, {'id': 'BG002', 'title': 'RVT-101 70 mg', 'description': 'Subjects dosed with two RVT-101 35 mg tablets\n\nRVT-101 70 mg: once daily, oral, 35-mg tablets'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '73.6', 'groupId': 'BG000', 'lowerLimit': '59', 'upperLimit': '86'}, {'value': '73.0', 'groupId': 'BG001', 'lowerLimit': '55', 'upperLimit': '85'}, {'value': '73.0', 'groupId': 'BG002', 'lowerLimit': '55', 'upperLimit': '86'}, {'value': '73.0', 'groupId': 'BG003', 'lowerLimit': '55', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '< 74 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '135', 'groupId': 'BG003'}]}]}, {'title': '>/= 74 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '133', 'groupId': 'BG003'}]}]}, {'title': '< 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': '>/=65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}, {'value': '240', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '255', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}, {'value': '268', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '256', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}, {'value': '266', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26.59', 'groupId': 'BG000', 'lowerLimit': '15.8', 'upperLimit': '39.2'}, {'value': '26.51', 'groupId': 'BG001', 'lowerLimit': '16.8', 'upperLimit': '42.1'}, {'value': '26.81', 'groupId': 'BG002', 'lowerLimit': '18.6', 'upperLimit': '41.6'}, {'value': '26.64', 'groupId': 'BG003', 'lowerLimit': '15.8', 'upperLimit': '42.1'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data was missing for two subjects'}], 'populationDescription': 'Safety Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-15', 'size': 1654581, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-12-17T15:00', 'hasProtocol': True}, {'date': '2017-11-14', 'size': 18122812, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-12-17T15:03', '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': 484}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-04', 'studyFirstSubmitDate': '2016-01-25', 'resultsFirstSubmitDate': '2018-12-31', 'studyFirstSubmitQcDate': '2016-01-27', 'lastUpdatePostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-04', 'studyFirstPostDateStruct': {'date': '2016-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale-Part III (UPDRS-III) Change From Baseline at Week 24", 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'The primary endpoint was to assess the effects of intepirdine versus placebo on the UPDRS Part III after 24 weeks of treatment. UPDRS Part III scores range from 0 to 108, with higher scores indicating worse outcome.'}], 'secondaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Change From Baseline at Week 24", 'timeFrame': 'Change from Baseline at 24 weeks', 'description': 'The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.'}, {'measure': "Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) Change From Baseline at Week 24", 'timeFrame': 'Change from Baseline at 24 weeks', 'description': "To assess the effects of RVT-101 versus placebo on global function as measured by the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC+) after 24 weeks of treatment. CIBIC+ is recorded on a 7-point scale with a score of 4 indicating no change, scores above 4 indicating worsening, and scores below 4 indicating improvement."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dementia with Lewy bodies', 'Lewy bodies', 'intepirdine', 'RVT-101', 'dementia'], 'conditions': ['Dementia With Lewy Bodies']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.', 'detailedDescription': 'The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.\n\nThe randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).\n\nSubjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subject with probable DLB\n* Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline\n* Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator\n* Patient has a reliable caregiver who is willing to report on the subject's status throughout the study\n* Patients currently receiving therapy for DLB are eligible for enrollment\n\nExclusion Criteria:\n\n* Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.\n* Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study."}, 'identificationModule': {'nctId': 'NCT02669433', 'briefTitle': 'Study 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