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

Medivation

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Dimebon; Drug: Placebo comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00829374

DIM18

Details and patient eligibility

About

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.

Enrollment: 1,003 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,003 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Dimebon, 5 mg orally three times daily

Treatment:

Drug: Dimebon

Drug: Dimebon

2

Experimental group

Description:

Dimebon, 20 mg orally three times daily

Treatment:

Drug: Dimebon

Drug: Dimebon

3

Placebo Comparator group

Description:

Placebo orally three times daily

Treatment:

Drug: Placebo comparator