Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil (CONCERT)
This study has been completed.
Sponsor:
Medivation, Inc.
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00829374
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Hide Study LocationsLocations
| 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 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 19, 2013