Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT00829816
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2009-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'C010119', 'term': 'latrepirdine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-06', 'studyFirstSubmitDate': '2009-01-12', 'studyFirstSubmitQcDate': '2009-01-23', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To assess the safety and tolerability of orally administered dimebon in patients with Alzheimer's disease (AD) on a stable dose and regimen of memantine, or memantine plus donepezil.", 'timeFrame': 'up to 28 days', 'description': 'Treatment discontinuation due to adverse events, the frequency and severity of adverse events, and clinically significant changes in safety assessments (including physical examination findings, vital signs, laboratory values, and ECGs) in the dimebon group will be compared to those reported in the placebo group.'}], 'secondaryOutcomes': [{'measure': 'To assess the steady-state pharmacokinetics (PK) of orally-administered dimebon in patients with AD on a stable dose and regimen of memantine, or memantine plus donepezil.', 'timeFrame': 'up to 28 days', 'description': 'The following key parameters will be used to assess the steady-state PK of dimebon: maximum plasma concentration (Cmax), time to maximum plasma concentration (tmax), Ctrough, area under the curve (AUC), and peak-to-trough ratio.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alzheimers disease', 'donepezil', 'memantine'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Alzheimer's disease\n* On Memantine\n* Caregiver who is willing to accompany the patient to all clinic visits\n\nExclusion Criteria:\n\n* Unstable medical illnesses or significant hepatic or renal disease\n* Other primary psychiatric or neurological disorders"}, 'identificationModule': {'nctId': 'NCT00829816', 'briefTitle': 'Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medivation, Inc.'}, 'officialTitle': "A Multi-Center Phase 1 Study of the Safety and Tolerability of Dimebon in Alzheimer's Disease Patients on Memantine (Cohort 1) and Memantine Plus Donepezil (Cohort 2)", 'orgStudyIdInfo': {'id': 'DIM17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dimebon', 'description': '20 mg dimebon by mouth 3 times per day', 'interventionNames': ['Drug: Dimebon']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '20 mg placebo by mouth 3 times per day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Dimebon', 'type': 'DRUG', 'armGroupLabels': ['Dimebon']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90720', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '33445', 'city': 'Delray Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.46146, 'lon': -80.07282}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medivation, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}