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Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil (CONCERT)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00829374
First received: January 23, 2009
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  Purpose

The purpose of this study is to determine if Dimebon is safe and effective in patients with mild to moderate Alzheimer's disease on Donepezil.


Condition Intervention Phase
Alzheimer's Disease
 Drug: Dimebon
Drug: Placebo comparator
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: CONCERT: A Phase 3 Multicenter, Randomized, Placebo-Controlled, Double-Blind Twelve-Month Safety and Efficacy Study Evaluating Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease on Donepezil

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Resource Utilization in Dementia Lite (RUD lite) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]
  • Euro Quality of Life 5 (EQ-5D) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Enrollment: 1003
Study Start Date: March 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dimebon, 5 mg orally three times daily
 Drug: Dimebon
5 mg orally three times daily
Experimental: 2
Dimebon, 20 mg orally three times daily
 Drug: Dimebon
20 mg orally three times daily
Placebo Comparator: 3
placebo orally three times daily
 Drug: Placebo comparator
Placebo 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:

  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829374

  Show 101 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Pfizer
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00829374     History of Changes
Other Study ID Numbers: DIM18
Study First Received: January 23, 2009
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Alzheimer's disease
clinical trial
mitochondria
memory loss
 neurodegenerative disease
dementia
investigational drug

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
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013