CClinicalTrials.gg
CompletedNCT00829374CONCERTUpdated Sep 27, 2016

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

A Phase 3 interventional study of Dimebon and Dimebon in Alzheimer's Disease, sponsored by Medivation, Inc.. Completed at 101 sites in 10 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2016-09-27.

Sponsored by Medivation, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,003
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • Alzheimer's disease
  • clinical trial
  • mitochondria
  • memory loss
  • neurodegenerative disease
  • dementia
  • investigational drug
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 1,003 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Medivation, Inc. is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Other causes of dementia
  • Major structural brain disease
  • Unstable medical condition or significant hepatic or renal disease
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,003 participants (actual)

Study arms

  • Experimental
    1

    Dimebon, 5 mg orally three times daily

    Drug: Dimebon

  • Experimental
    2

    Dimebon, 20 mg orally three times daily

    Drug: Dimebon

  • Placebo comparator
    3

    Placebo orally three times daily

    Drug: Placebo comparator

Interventions

  • DrugDimebon

    5 mg orally three times daily

  • DrugDimebon

    20 mg orally three times daily

  • DrugPlacebo comparator

    Placebo orally three times daily

06

What researchers measure

Primary outcomes

  1. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

    Time frame: Week 52

  2. Alzheimer's Disease Assessment Scale - Cognitive Subscale

    Time frame: Week 52

Secondary outcomes

  1. Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)

    Time frame: Week 52

  2. Neuropsychiatric Inventory (NPI)

    Time frame: Week 52

  3. Resource Utilization in Dementia Lite (RUD lite)

    Time frame: Week 52

  4. Euro Quality of Life 5 (EQ-5D)

    Time frame: Week 52

07

Study locations

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

Showing the first 100 of 101 sites across 10 countries.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00829374
Lead sponsor
Medivation, Inc.
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Jan 27, 2009
Start date
Mar 2009
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Sep 27, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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