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

Phase 3

Terminated

• Conditions: Moderate to Severe Alzheimer
• Interventions: Drug: Dimebon (latrepirdine); Drug: Placebo

• Registration Number: NCT00954590
• Lead Sponsor: Medivation, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Study Start: 2009-10
• Primary Completion: 2010-08
• Status Verified: 2016-09
• Disposition First Submitted: 2016-09-24
• Disposition First Submitted QC: 2016-09-24
• Last Update Submitted: 2016-09-24
• Disposition First Posted: 2016-09-27
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 89

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

Read More

Exclusion Criteria

• Other causes of dementia
• Major structural brain disease
• Unstable medical condition or significant hepatic or renal disease

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dimebon (latrepirdine)	Dimebon (latrepirdine)	Dimebon, 20 mg orally three times daily
Placebo	Placebo	Placebo orally three times daily

Primary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory (NPI)	26 weeks post baseline	To evaluate the efficacy of dimebon (latrepirdine) as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI)
Activities of Daily Living (severe) (ADCS ADLsev)	26 weeks post baseline	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).