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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:
ClinicalTrials.gov Identifier:
NCT00829374
First Posted: January 27, 2009
Last Update Posted: September 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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:


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 ]
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale [ Time Frame: Week 52 ]

Secondary Outcome Measures:
  • Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus) [ Time Frame: Week 52 ]
  • Neuropsychiatric Inventory (NPI) [ Time Frame: Week 52 ]
  • Resource Utilization in Dementia Lite (RUD lite) [ Time Frame: Week 52 ]
  • Euro Quality of Life 5 (EQ-5D) [ Time Frame: Week 52 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Mild-to-moderate Alzheimer's disease (AD)
  • Probable AD (Diagnostic Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR))
  • Mini-Mental State Examination (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00829374


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

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00829374     History of Changes
Other Study ID Numbers: DIM18
First Submitted: January 23, 2009
First Posted: January 27, 2009
Last Update Posted: September 27, 2016
Last Verified: September 2016

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
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents