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

March 31, 2011 updated by: Eisai Inc.

A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia
    • Queensland
      • Brisbane, Queensland, Australia
    • South Australia
      • Woodville South, South Australia, Australia
    • Victoria
      • Heidelberg West, Victoria, Australia
    • Western Australia
      • Nedlands, Western Australia, Australia
  • Canada
    • Ontario
      • Toronto, Ontario, Canada
  • France
      • Paris, France
        • Hôpital Broca-La Rochefoucauld
  • Ireland
      • Belfast, Ireland
  • United Kingdom
      • Bath, United Kingdom
      • Blackpool, United Kingdom
      • Bradford, United Kingdom
    • East Sussex
      • St. Leonards on Sea, East Sussex, United Kingdom
    • Southampton
      • West End, Southampton, United Kingdom
    • Wilshire
      • Swindon, Wilshire, United Kingdom
  • United States
    • Alabama
      • Northport, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Sun City, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • San Francisco, California, United States
      • Santa Monica, California, United States
      • Torrance, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Florida
      • Ft. Lauderdale, Florida, United States
      • Ft. Myers, Florida, United States
      • North Miami, Florida, United States
      • St. Petersburg, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • New Jersey
      • Long Branch, New Jersey, United States
      • Piscataway, New Jersey, United States
    • New York
      • New Hyde Park, New York, United States
    • North Carolina
      • Greenville, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Centerville, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Medford, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States
    • Texas
      • Austin, Texas, United States
      • Houston, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessments of global and cognitive function of Severe AD patients

Secondary Outcome Measures

Outcome Measure
Assessment of behavior and performance on Activity of Daily Living in severe AD patients
Assessment of caregiver burden

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Collaborators

Pfizer

Investigators

  • Study Director: Sharon Richardson, Ph.D., Eisai Inc.
  • Study Director: Honglan Li, Ph.D., Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 9, 2004

First Posted (Estimate)

November 10, 2004

Study Record Updates

Last Update Posted (Estimate)

April 1, 2011

Last Update Submitted That Met QC Criteria

March 31, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2020-A001-315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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