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

Completed · Phase 3

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00097916

Run by

Forest Laboratories

People needed

34

Starts

2004-09-01

Expected to finish

2006-04-01

Last updated by the study team

2012-03-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• The Forves Norris MDA/ALS Research Center — San Francisco, California, United States
• Coastal Communities Hospital — Westminster, California, United States
• Alzheimer's Disease Research Unit — New Haven, Connecticut, United States
• Berma Research Group — Hialeah, Florida, United States
• Baumel-Eisner Neuromedical Institute — Miami, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Geriatric Medicine — Honolulu, Hawaii, United States
• The Memory Clinic — Bennington, Vermont, United States
• Hampton Roads Center for Clinical Research — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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