Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
- Registration Number
- NCT00829374
- Lead Sponsor
- Medivation, Inc.
- Brief Summary
The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1003
Inclusion Criteria
- Mild-to-moderate Alzheimer's disease (AD)
- Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR))
- Mini-Mental State Examination (MMSE) score between 12 and 24, inclusive
- Stable on donepezil for at least 6 months
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Exclusion Criteria
- Other causes of dementia
- Major structural brain disease
- Unstable medical condition or significant hepatic or renal disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Dimebon Dimebon, 5 mg orally three times daily 3 Placebo comparator Placebo orally three times daily 2 Dimebon Dimebon, 20 mg orally three times daily
- Primary Outcome Measures
Name Time Method Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Week 52 Alzheimer's Disease Assessment Scale - Cognitive Subscale Week 52
- Secondary Outcome Measures
Name Time Method Euro Quality of Life 5 (EQ-5D) Week 52 Resource Utilization in Dementia Lite (RUD lite) Week 52 Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) Week 52 Neuropsychiatric Inventory (NPI) Week 52