Status:
COMPLETED
Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Lead Sponsor:
Medivation, Inc.
Collaborating Sponsors:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
Exclusion
- Other causes of dementia
- Major structural brain disease
- Unstable medical condition or significant hepatic or renal disease
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
1003 Patients enrolled
Trial Details
Trial ID
NCT00829374
Start Date
March 1 2009
End Date
December 1 2011
Last Update
September 27 2016
Active Locations (101)
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1
Phoenix, Arizona, United States, 85006
2
Sun City, Arizona, United States, 85351
3
Tucson, Arizona, United States, 85724
4
Costa Mesa, California, United States, 92626