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An Extension of the CONCERT Protocol (DIM18) (CONCERT PLUS)

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ClinicalTrials.gov Identifier: NCT01152216
Recruitment Status : Terminated
First Posted : June 29, 2010
Last Update Posted : September 27, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Dimebon Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 672 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension of the CONCERT Protocol (DIM18) Evaluating Dimebon (Latrepirdine) in Patients With Alzheimer's Disease
Study Start Date : April 2010
Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Dimebon Drug: Dimebon
20 mg orally three times daily


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
More Information

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01152216     History of Changes
Other Study ID Numbers: DIM18EXT
First Posted: June 29, 2010    Key Record Dates
Last Update Posted: September 27, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders