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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:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.

June 25, 2010
June 29, 2010
September 27, 2016
April 2010
May 2012   (Final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01152216 on ClinicalTrials.gov Archive Site
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An Extension of the CONCERT Protocol (DIM18)
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.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: Dimebon
20 mg orally three times daily
Experimental: Dimebon
Intervention: Drug: Dimebon
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
672
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May 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
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NCT01152216
DIM18EXT
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Medivation, Inc.
Medivation, Inc.
Pfizer
Not Provided
Medivation, Inc.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP