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
  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:


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
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, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85006
Sun City, Arizona, United States, 85351
Tucson, Arizona, United States, 85724
United States, California
Costa Mesa, California, United States, 92626
Encino, California, United States, 91316
Escondido, California, United States, 92025
Fresno, California, United States, 93720
Garden Grove, California, United States, 92845
La Jolla, California, United States, 92037
Los Alamitos, California, United States, 90720
Los Angeles, California, United States, 90095
Martinez, California, United States, 94553
Newport, California, United States, 92660
Paramount, California, United States, 90723
Pasadena, California, United States, 91105
San Diego, California, United States, 92103
San Francisco, California, United States, 94143
United States, Colorado
Boulder, Colorado, United States, 80304
Denver, Colorado, United States, 80218
United States, Connecticut
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington, District of Columbia, United States, 20057
United States, Florida
Deerfield Beach, Florida, United States, 33064
Delray Beach, Florida, United States, 33445
Jacksonville, Florida, United States, 32224
Miami, Florida, United States, 33137
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta, Georgia, United States, 30329
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Indiana
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Eaton, Maryland, United States, 21601
United States, Massachusetts
Boston, Massachusetts, United States, 02118
United States, Michigan
Ann Arbor, Michigan, United States, 48105
United States, Nevada
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Mt Arlington, New Jersey, United States, 07865
Princeton, New Jersey, United States, 08540
United States, New York
Albany, New York, United States, 12208
Cedarhurst, New York, United States, 11516
New York, New York, United States, 10029
Rochester, New York, United States, 14620
United States, North Carolina
Durham, North Carolina, United States, 27710
United States, Ohio
Beachwood, Ohio, United States, 44122
Toledo, Ohio, United States, 43623
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Norristown, Pennsylvania, United States, 19401
United States, Rhode Island
Providence, Rhode Island, United States, 02906
United States, Texas
Austin, Texas, United States, 78757
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
United States, Virginia
Charlottesville, Virginia, United States, 22903
United States, Washington
Seattle, Washington, United States, 98108
United States, Wisconsin
Middleton, Wisconsin, United States, 53562
Australia, New South Wales
Newcastle, New South Wales, Australia
Sydney, New South Wales, Australia
Australia, Queensland
Brisbane, Queensland, Australia
Australia, South Australia
Adelaide, South Australia, Australia
Australia, Victoria
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Australia, Western Australia
Perth, Western Australia, Australia
Belgium
Antwerp, Belgium
Leuven, Belgium
Sint-Truiden, Belgium
Finland
Kuppio, Finland
Oulu, Finland
Turku, Finland
France
Bordeaux, France
Concert, France
Lille, France
Montpellier, France
Nice, France
Toulouse, France
Germany
Berlin, Germany
Bochum, Germany
Freiburg, Germany
Hattingen, Germany
Mannheim, Germany
Munich, Germany
Italy
Brescia, Italy
Florence, Italy
Genoa, Italy
Perugia, Italy
Rome, Italy
New Zealand
Christchurch, Canterbury, New Zealand
Auckland, New Zealand
Sweden
Malmo, Sweden
Norrkoping, Sweden
Stockholm, Sweden
United Kingdom
Brentford, Middlesex, United Kingdom
Rushden, Northhamptonshire, United Kingdom
Glasgow, Scotland, United Kingdom
Worthington, West Sussex, United Kingdom
Bath, United Kingdom
Blackpool, United Kingdom
Bradford, United Kingdom
Greater Manchester, United Kingdom
London, United Kingdom
Newcastle upon Tyne, United Kingdom
Norfolk, United Kingdom
Oxford, United Kingdom
Southampton, United Kingdom
Swindon, United Kingdom
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

ClinicalTrials.gov processed this record on September 18, 2014