An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease

Phase 3

Completed

• Conditions: Alzheimer's Disease

• Registration Number: NCT00097916
• Lead Sponsor: Forest Laboratories

Brief Summary

About 65% of patients with severe Alzheimer's Disease (AD) will have symptoms of agitation. There are drawbacks associated with the currently available therapeutic interventions for agitation associated with Alzheimer's Disease. In a recent trial, in the group of patients with moderate to severe AD treated with memantine, there were fewer incidences of agitation. It is hypothesized that memantine will be effective in reducing the symptoms of agitation associated with moderate to severe Alzheimer's Disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2004-12-01
• Study First Submitted QC: 2004-12-01
• Study First Posted: 2004-12-02
• Primary Completion: 2006-04
• Study Completion: 2006-04
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 on agitation/aggression domain of NPI
• Stable dose of donepezil for 3 months

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Exclusion Criteria

• Other evidence of psychiatric disorders
• Oncologic diagnosis
• Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neuropsychiatric Inventory

Secondary Outcome Measures

Name	Time	Method
Cohen Mansfield Agitation Inventory
Clinical Global Impression Scale
ADCS-ADL
Agitation/aggression domain of Neuropsychiatric Inventory (NPI)

Trial Locations

Locations (9)

The Forves Norris MDA/ALS Research Center; 🇺🇸 San Francisco, California, United States

Coastal Communities Hospital; 🇺🇸 Westminster, California, United States

Berma Research Group; 🇺🇸 Hialeah, Florida, United States

Baumel-Eisner Neuromedical Institute; 🇺🇸 Miami, Florida, United States

The Memory Clinic; 🇺🇸 Bennington, Vermont, United States

Hampton Roads Center for Clinical Research; 🇺🇸 Norfolk, Virginia, United States

Premiere Research Institute; 🇺🇸 West Palm Beach, Florida, United States

Geriatric Medicine; 🇺🇸 Honolulu, Hawaii, United States

Alzheimer's Disease Research Unit; 🇺🇸 New Haven, Connecticut, United States