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

September 24, 2016 updated by: Medivation, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1003

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia
      • Sydney, New South Wales, Australia
    • Queensland
      • Brisbane, Queensland, Australia
    • South Australia
      • Adelaide, South Australia, Australia
    • Victoria
      • Geelong, Victoria, Australia
      • Melbourne, Victoria, 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
      • Auckland, New Zealand
    • Canterbury
      • Christchurch, Canterbury, New Zealand
  • Sweden
      • Malmo, Sweden
      • Norrkoping, Sweden
      • Stockholm, Sweden
  • 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
    • Middlesex
      • Brentford, Middlesex, United Kingdom
    • Northhamptonshire
      • Rushden, Northhamptonshire, United Kingdom
    • Scotland
      • Glasgow, Scotland, United Kingdom
    • West Sussex
      • Worthington, West Sussex, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
      • Sun City, Arizona, United States, 85351
      • Tucson, Arizona, United States, 85724
    • 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
    • Colorado
      • Boulder, Colorado, United States, 80304
      • Denver, Colorado, United States, 80218
    • Connecticut
      • New Haven, Connecticut, United States, 06510
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
    • 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
    • Georgia
      • Atlanta, Georgia, United States, 30329
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Indiana
      • Indianapolis, Indiana, United States, 46260
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Maryland
      • Eaton, Maryland, United States, 21601
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
    • Nevada
      • Las Vegas, Nevada, United States, 89106
    • New Jersey
      • Mt Arlington, New Jersey, United States, 07865
      • Princeton, New Jersey, United States, 08540
    • 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
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Beachwood, Ohio, United States, 44122
      • Toledo, Ohio, United States, 43623
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
      • Norristown, Pennsylvania, United States, 19401
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
    • Texas
      • Austin, Texas, United States, 78757
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
    • Virginia
      • Charlottesville, Virginia, United States, 22903
    • Washington
      • Seattle, Washington, United States, 98108
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Dimebon, 5 mg orally three times daily
Drug: Dimebon
5 mg orally three times daily
Drug: Dimebon
20 mg orally three times daily
EXPERIMENTAL: 2
Dimebon, 20 mg orally three times daily
Drug: Dimebon
5 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time Frame: Week 52
Week 52
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time Frame: Week 52
Week 52

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medivation, Inc.

Collaborators

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

January 23, 2009

First Submitted That Met QC Criteria

January 23, 2009

First Posted (ESTIMATE)

January 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2016

Last Update Submitted That Met QC Criteria

September 24, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIM18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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