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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00829374

Acronym

CONCERT

Enrollment

1003

Registered

2009-01-27

Start date

2009-03-31

Completion date

2011-12-31

Last updated

2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

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

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.

Interventions

DRUGDimebon

5 mg orally three times daily

DRUGPlacebo comparator

Placebo orally three times daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia, Belgium, Finland, France, Germany, Italy, New Zealand, Sweden, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026