Back to resultsAn Extension of the CONCERT Protocol (DIM18) (CONCERT PLUS)
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dimebon
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dimebon
Arm Description
Outcomes
Primary Outcome Measures
Safety
To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.
Secondary Outcome Measures
Full Information
NCT ID
NCT01152216
First Posted
June 25, 2010
Last Updated
September 26, 2016
Sponsor
Medivation, Inc.
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT01152216
Brief Title
An Extension of the CONCERT Protocol (DIM18)
Acronym
CONCERT PLUS
Official Title
An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
Collaborators
Pfizer
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
672 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dimebon
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Dimebon
Intervention Description
20 mg orally three times daily
Primary Outcome Measure Information:
Title
Safety
Description
To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.
Time Frame
Through study discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Learn more about this trial
An Extension of the CONCERT Protocol (DIM18)
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