An Extension of the CONCERT Protocol (DIM18) (CONCERT PLUS)

Medivation

Status and phase: Terminated; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: Dimebon

Study type: Interventional

Funder types: Industry

Identifiers

NCT01152216

DIM18EXT

Details and patient eligibility

About

An open-label extension study of the CONCERT (DIM18) protocol evaluating the safety of dimebon (latrepirdine) in subjects with With Mild-to-Moderate Alzheimer's Disease on Donepezil.

Enrollment: 672 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful completion of the 12 month DIM18 CONCERT study
• Mild-to-moderate Alzheimer's disease
• Probable AD, Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revised (DSM-IV-TR)
• Mini-Mental State Exam (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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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672 participants in 1 patient group

Dimebon

Experimental group

Treatment:

Drug: Dimebon