An Extension of the CONCERT Protocol (DIM18)

Phase 3TerminatedNCT01152216

Medivation, Inc.672 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

672

Conditions

Alzheimer's Disease

Interventions

DimebonDRUG

20 mg orally three times daily

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety

To evaluate the long-term safety and tolerability of dimebon (latrepirdine) in Alzheimer's disease (AD) patients who have completed 52 weeks of blinded treatment in the DIM18 (CONCERT) protocol.

Time frame: Through study discontinuation

Data from ClinicalTrials.gov

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