- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01152216
An Extension of the CONCERT Protocol (DIM18) (CONCERT PLUS)
September 26, 2016 updated by: Medivation, Inc.
An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients With Alzheimer's Disease
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
672
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dimebon
|
20 mg orally three times daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: Through study discontinuation
|
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.
|
Through study discontinuation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2010
Primary Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
June 25, 2010
First Submitted That Met QC Criteria
June 28, 2010
First Posted (Estimate)
June 29, 2010
Study Record Updates
Last Update Posted (Estimate)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 26, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIM18EXT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
University of Southern CaliforniaAlzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...RecruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
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University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaboratorsActive, not recruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
-
Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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Novoic LimitedTerminatedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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Novoic LimitedTerminatedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Alzheimer's Clinical Trials Consortium (ACTC)Enrolling by invitationPreclinical Alzheimer's Disease | Early Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal CognitionUnited States
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University Hospital, BordeauxMinistry for Health and Solidarity, FranceCompletedAlzheimer's Disease (AD) | Alzheimer's Disease (AD) Related DisordersFrance
Clinical Trials on Dimebon
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PfizerMedivation, Inc.CompletedHuntington Disease | Alzheimer's DiseaseUnited States
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PfizerMedivation, Inc.CompletedAlzheimer's Disease | Huntington's DiseaseUnited States
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PfizerMedivation, Inc.CompletedAlzheimer's Disease | Huntington's DiseaseUnited States
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PfizerMedivation, Inc.Completed
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PfizerMedivation, Inc.Completed
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Medivation, Inc.Huntington Study GroupCompletedHuntington's DiseaseUnited States
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PfizerMedivation, Inc.CompletedAlzheimer's Disease | Huntington's DiseaseUnited States
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PfizerMedivation, Inc.CompletedAlzheimer's DiseaseCanada, United States, Puerto Rico
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Medivation, Inc.PfizerCompletedHuntington DiseaseGermany, Canada, United States, Denmark, United Kingdom, Australia, Sweden
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Medivation, Inc.PfizerTerminated