Status:
TERMINATED
An Extension of the CONCERT Protocol (DIM18)
Lead Sponsor:
Medivation, Inc.
Collaborating Sponsors:
Pfizer
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.
Eligibility Criteria
Inclusion
- Successful completion of the 12 month DIM18 CONCERT study
- Mild-to-moderate Alzheimer's disease
- Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR)
- Mini-Mental State Exam (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 :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT01152216
Start Date
April 1 2010
Last Update
September 27 2016
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