Trial record 2 of 2 for:    dimebon CONCERT

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

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01152216
First received: June 25, 2010
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: Dimebon
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: Through study discontinuation ] [ Designated as safety issue: No ]
    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.


Enrollment: 672
Study Start Date: April 2010
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dimebon Drug: Dimebon
20 mg orally three times daily

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Successful completion of the 12 month DIM18 CONCERT study
  • Mild-to-moderate Alzheimer's disease
  • Probable AD (DSM-IV-TR)
  • 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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01152216     History of Changes
Other Study ID Numbers: DIM18EXT
Study First Received: June 25, 2010
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014