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CONCERT

CompletedPhase 3

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

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

Lead sponsor

Medivation, Inc.

Asset

Dimebon

Listed sites

101

Recruiting sites

-

Enrollment

1,003

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 12-24

Primary endpoints

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

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDDIM18
NCT IDNCT00829374

Timeline

Milestones

Study first posted2009-01-27estimated
Study start2009-03 (month precision)
Primary completion2011-12actual (month precision)
Study completion2011-12actual (month precision)
Last update posted2016-09-27estimated

Assets

Drug assets

Dimebon

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Caregiver / quality of life
3
Function / daily living
1
Behavior / neuropsychiatric
1
Other (unclassified)
1

Function / daily living

1 endpoint
Primary/protocol endpoint

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

Time frame:Week 52

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

Neuropsychiatric Inventory (NPI)

Time frame:Week 52

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

3 endpoints
Secondary/protocol endpoint

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

Time frame:Week 52

descriptive

Secondary/protocol endpoint

Resource Utilization in Dementia Lite (RUD lite)

Time frame:Week 52

descriptive

Secondary/protocol endpoint

Euro Quality of Life 5 (EQ-5D)

Time frame:Week 52

descriptive

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Alzheimer's Disease Assessment Scale - Cognitive Subscale

Time frame:Week 52

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.