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Sponsored by: |
Medivation |
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Information provided by: | Medivation |
ClinicalTrials.gov Identifier: | NCT00377715 |
This study will evaluate the safety and potential benefit of Dimebon as compared to placebo in patients with mild to moderate Alzheimer's Disease.
Condition | Intervention | Phase |
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Alzheimer's Disease |
Drug: Dimebon |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 2, Double-Blind, Placebo-Controlled Study of Oral Dimebon in Subjects With Mild to Moderate Alzheimer's Disease |
Enrollment: | 183 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Dimebon
Dimebon 20 mg three times a day x 52 weeks
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Participation in an investigational drug or device study within 30 days prior to study entry, or 60 days prior to study entry if the investigational drug study involved therapy for Alzheimer's Disease.
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Responsible Party: | Medivation, Inc. ( Mohammad Hirmand ) |
Study ID Numbers: | DIM02 |
Study First Received: | September 15, 2006 |
Last Updated: | December 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00377715 |
Health Authority: | Russia: Ministry of Health and Social Development of the Russian Federation |
Dimebon, Alzheimer's Disease, ADAS-cog, Clinical Global Impression of Change |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases Tauopathies |