An Extension of the CONCERT Protocol (DIM18)

Last updated: September 26, 2016
Sponsor: Medivation, Inc.
Overall Status: Terminated

Phase

3

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

N/A

Clinical Study ID

NCT01152216
DIM18EXT
  • Ages > 50
  • All Genders

Study 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

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

Exclusion Criteria:

  • Other causes of dementia

  • Major structural brain disease

  • Unstable medical condition or significant hepatic or renal disease

Study Design

Total Participants: 672
Study Start date:
April 01, 2010
Estimated Completion Date: