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

Last updated: March 1, 2012
Sponsor: Forest Laboratories
Overall Status: Completed

Phase

3

Condition

Alzheimer's Disease

Dementia

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00097916
MEM-MD-23
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 onagitation/aggression domain of NPI

  • Stable dose of donepezil for 3 months

Exclusion

Exclusion Criteria:

  • Other evidence of psychiatric disorders

  • Oncologic diagnosis

  • Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovasculardisease

Study Design

Total Participants: 34
Study Start date:
September 01, 2004
Estimated Completion Date:
April 30, 2006

Connect with a study center

  • The Forves Norris MDA/ALS Research Center

    San Francisco, California 94115
    United States

    Site Not Available

  • Coastal Communities Hospital

    Westminster, California 92683
    United States

    Site Not Available

  • Alzheimer's Disease Research Unit

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Berma Research Group

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Baumel-Eisner Neuromedical Institute

    Miami, Florida 33154
    United States

    Site Not Available

  • Premiere Research Institute

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Geriatric Medicine

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • The Memory Clinic

    Bennington, Vermont 05201
    United States

    Site Not Available

  • Hampton Roads Center for Clinical Research

    Norfolk, Virginia 23502
    United States

    Site Not Available

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