Clinical Trial: Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezi
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 Summary:
Sponsor: Medivation, Inc.
Current Primary Outcome:
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Week 52 ]
- Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Week 52 ]
Original Primary Outcome:
- Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) [ Time Frame: Baseline, Weeks 13, 26, 39, and 52 ]
- Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, Weeks 12, 26, 39 and 52 ]
Current Secondary Outcome:
- Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) [ Time Frame: Week 52 ]
- Neuropsychiatric Inventory (NPI) [ Time Frame: Week 52 ]
- Resource Utilization in Dementia Lite (RUD lite) [ Time Frame: Week 52 ]
- Euro Quality of Life 5 (EQ-5D) [ Time Frame: Week 52 ]
Original Secondary Outcome:
- Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) [ Time Frame: Baseline, Weeks 12, 26,39 and 52 ]
- Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Weeks 13, 26, 39 and 52 ]
- Resource Utilization in Dementia Lite (RUD lite) [ Time Frame: Baseline, Weeks 26 and 52 ]
- Euro Quality of Life 5 (EQ-5D) [ Time Frame: Baseline, Weeks 26 and 52 ]
Information By: Medivation, Inc.
Dates:
Date Received: January 23, 2009
Date Started: March 2009
Date Completion:
Last Updated: September 24, 2016
Last Verified: September 2016
