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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dimebon
Dimebon
Placebo comparator
Sponsored by
Medivation, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease, clinical trial, mitochondria, memory loss, neurodegenerative disease, dementia, investigational drug

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Dimebon, 5 mg orally three times daily

Dimebon, 20 mg orally three times daily

Placebo orally three times daily

Outcomes

Primary Outcome Measures

Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Alzheimer's Disease Assessment Scale - Cognitive Subscale

Secondary Outcome Measures

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

Full Information

First Posted
January 23, 2009
Last Updated
September 24, 2016
Sponsor
Medivation, Inc.
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00829374
Brief Title
Safety and Efficacy Study Evaluating Dimebon in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Acronym
CONCERT
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease, clinical trial, mitochondria, memory loss, neurodegenerative disease, dementia, investigational drug

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1003 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Dimebon, 5 mg orally three times daily
Arm Title
2
Arm Type
Experimental
Arm Description
Dimebon, 20 mg orally three times daily
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo orally three times daily
Intervention Type
Drug
Intervention Name(s)
Dimebon
Intervention Description
5 mg orally three times daily
Intervention Type
Drug
Intervention Name(s)
Dimebon
Intervention Description
20 mg orally three times daily
Intervention Type
Drug
Intervention Name(s)
Placebo comparator
Intervention Description
Placebo orally three times daily
Primary Outcome Measure Information:
Title
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time Frame
Week 52
Title
Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Clinician's Interview Based Impression of Change, plus caregiver input (CIBIC-plus)
Time Frame
Week 52
Title
Neuropsychiatric Inventory (NPI)
Time Frame
Week 52
Title
Resource Utilization in Dementia Lite (RUD lite)
Time Frame
Week 52
Title
Euro Quality of Life 5 (EQ-5D)
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
City
Encino
State/Province
California
ZIP/Postal Code
91316
Country
United States
City
Escondido
State/Province
California
ZIP/Postal Code
92025
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
City
Newport
State/Province
California
ZIP/Postal Code
92660
Country
United States
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20057
Country
United States
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
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Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
Eaton
State/Province
Maryland
ZIP/Postal Code
21601
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
City
Mt Arlington
State/Province
New Jersey
ZIP/Postal Code
07865
Country
United States
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
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Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19401
Country
United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
City
Newcastle
State/Province
New South Wales
Country
Australia
City
Sydney
State/Province
New South Wales
Country
Australia
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Brisbane
State/Province
Queensland
Country
Australia
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Adelaide
State/Province
South Australia
Country
Australia
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Geelong
State/Province
Victoria
Country
Australia
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Melbourne
State/Province
Victoria
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Australia
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Perth
State/Province
Western Australia
Country
Australia
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Antwerp
Country
Belgium
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Leuven
Country
Belgium
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Sint-Truiden
Country
Belgium
City
Kuppio
Country
Finland
City
Oulu
Country
Finland
City
Turku
Country
Finland
City
Bordeaux
Country
France
City
Concert
Country
France
City
Lille
Country
France
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Montpellier
Country
France
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Nice
Country
France
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Toulouse
Country
France
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Berlin
Country
Germany
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Bochum
Country
Germany
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Freiburg
Country
Germany
City
Hattingen
Country
Germany
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Mannheim
Country
Germany
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Munich
Country
Germany
City
Brescia
Country
Italy
City
Florence
Country
Italy
City
Genoa
Country
Italy
City
Perugia
Country
Italy
City
Rome
Country
Italy
City
Christchurch
State/Province
Canterbury
Country
New Zealand
City
Auckland
Country
New Zealand
City
Malmo
Country
Sweden
City
Norrkoping
Country
Sweden
City
Stockholm
Country
Sweden
City
Brentford
State/Province
Middlesex
Country
United Kingdom
City
Rushden
State/Province
Northhamptonshire
Country
United Kingdom
City
Glasgow
State/Province
Scotland
Country
United Kingdom
City
Worthington
State/Province
West Sussex
Country
United Kingdom
City
Bath
Country
United Kingdom
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Blackpool
Country
United Kingdom
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Bradford
Country
United Kingdom
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Greater Manchester
Country
United Kingdom
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London
Country
United Kingdom
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Newcastle upon Tyne
Country
United Kingdom
City
Norfolk
Country
United Kingdom
City
Oxford
Country
United Kingdom
City
Southampton
Country
United Kingdom
City
Swindon
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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