Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease

Last updated: March 31, 2011
Sponsor: Eisai Inc.
Overall Status: Completed

Phase

3

Condition

Alzheimer's Disease

Memory Loss

Dementia

Treatment

N/A

Clinical Study ID

NCT00096473
E2020-A001-315
  • Ages > 50
  • All Genders

Study Summary

Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.

Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinically diagnosed Alzheimer's Disease with MMSE score 1~12

  • Have not been treated by any medication for Alzheimer's Disease in past 3 months

  • Live in community or Assisted Living Facility

  • Healthy or with chronic diseases that are medically controlled or stabilized

  • Able to swallow tablets

Exclusion

Exclusion Criteria:

  • Any primary neurological or psychiatric diagnosis (including depressive disorder)other than Alzheimer's Disease

  • Dementia caused by organic diseases other than Alzheimer's Disease

Study Design

Total Participants: 229
Study Start date:
January 01, 2001
Estimated Completion Date:
September 30, 2005

Connect with a study center

  • Randwick, New South Wales
    Australia

    Site Not Available

  • Brisbane, Queensland
    Australia

    Site Not Available

  • Woodville South, South Australia
    Australia

    Site Not Available

  • Heidelberg West, Victoria
    Australia

    Site Not Available

  • Nedlands, Western Australia
    Australia

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Hôpital Broca-La Rochefoucauld

    Paris,
    France

    Site Not Available

  • Belfast,
    Ireland

    Site Not Available

  • St. Leonards on Sea, East Sussex
    United Kingdom

    Site Not Available

  • West End, Southampton
    United Kingdom

    Site Not Available

  • Swindon, Wilshire
    United Kingdom

    Site Not Available

  • Bath,
    United Kingdom

    Site Not Available

  • Blackpool,
    United Kingdom

    Site Not Available

  • Bradford,
    United Kingdom

    Site Not Available

  • Northport, Alabama
    United States

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • Sun City, Arizona
    United States

    Site Not Available

  • Tucson, Arizona
    United States

    Site Not Available

  • San Francisco, California
    United States

    Site Not Available

  • Santa Monica, California
    United States

    Site Not Available

  • Torrance, California
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Ft. Lauderdale, Florida
    United States

    Site Not Available

  • Ft. Myers, Florida
    United States

    Site Not Available

  • North Miami, Florida
    United States

    Site Not Available

  • St. Petersburg, Florida
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • New Orleans, Louisiana
    United States

    Site Not Available

  • Springfield, Massachusetts
    United States

    Site Not Available

  • Long Branch, New Jersey
    United States

    Site Not Available

  • Piscataway, New Jersey
    United States

    Site Not Available

  • New Hyde Park, New York
    United States

    Site Not Available

  • Greenville, North Carolina
    United States

    Site Not Available

  • Raleigh, North Carolina
    United States

    Site Not Available

  • Centerville, Ohio
    United States

    Site Not Available

  • Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Medford, Oregon
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Jenkintown, Pennsylvania
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

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