An Extension of the CONCERT Protocol (DIM18)

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medivation, Inc.
• Collaborator: Pfizer

Criteria

Inclusion Criteria:

• 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 Criteria:

• Other causes of dementia

• Major structural brain disease

• Unstable medical condition or significant hepatic or renal disease