Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil - Full Text View

Sponsor:	Medivation, Inc.
Collaborator:	Pfizer
Information provided by:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00829374

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 III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

Drug Information available for: E 2020 Donepezil Dimebolin

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 ]

Estimated Enrollment:	1050
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Dimebon, 5 mg orally three times daily	Drug: Dimebon 5 mg orally three times daily
2: Experimental Dimebon, 20 mg orally three times daily	Drug: Dimebon 20 mg orally three times daily
3: Placebo Comparator placebo orally three times daily	Drug: Placebo comparator Placebo orally three times daily

Contacts and Locations

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

Contacts

Contact: Anthony Golsorkhi, MD	415-829-4196	anthony.golsorkhi@medivation.com
Contact: Stewart Hallett, MBA	415-829-4113	stewart.hallett@medivation.com

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Locations

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

Sponsors and Collaborators

Medivation, Inc.

Pfizer

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

Responsible Party:	Medivation, Inc. ( Andria Langenberg, MD / Vice President, Clinical Development )
ClinicalTrials.gov Identifier:	NCT00829374 History of Changes
Other Study ID Numbers:	DIM18
Study First Received:	January 23, 2009
Last Updated:	January 20, 2010
Health Authority:	United States: Food and Drug Administration