A Safety and Efficacy Study Evaluating Dimebon (Latrepirdine) in Patients With Moderate to Severe Alzheimer's Disease

Phase 3TerminatedNCT00954590

Medivation, Inc.89 enrolled

Overview

The purpose of this study is to determine if Dimebon is safe and effective in patients with moderate to severe Alzheimer's disease.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Moderate to Severe Alzheimer

Interventions

Dimebon (latrepirdine)DRUG

20 mg orally three times daily

PlaceboDRUG

Placebo orally three times daily

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Moderate-to-Severe Alzheimer's disease * Mini-Mental State Examination (MMSE) Score between 5 to 14, 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

Locations (2)

Unnamed facility

Santiago, Chile

Unnamed facility

Glasgow, Scotland, United Kingdom

Outcomes

Primary Outcomes

Neuropsychiatric Inventory (NPI)

To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI)

Time frame: 26 weeks post baseline

Activities of Daily Living (severe) (ADCS ADLsev)

To evaluate the efficacy of dimebon as compared to placebo on a measure of self-care and daily function, the Alzheimer's Disease Cooperative Study - Activities of Daily Living (severe) (ADCS ADLsev).

Time frame: 26 weeks post baseline

Data from ClinicalTrials.gov

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