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

NCT ID: NCT00096473

Last Updated: 2011-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Donepezil hydrochloride

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Eisai Inc.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Sharon Richardson, Ph.D.

Role: STUDY_DIRECTOR

Eisai Inc.

Honglan Li, Ph.D.

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

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Northport, Alabama, United States

Site Status

Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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North Miami, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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New Orleans, Louisiana, United States

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Springfield, Massachusetts, United States

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Long Branch, New Jersey, United States

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Piscataway, New Jersey, United States

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New Hyde Park, New York, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Centerville, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Jenkintown, Pennsylvania, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Randwick, New South Wales, Australia

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Brisbane, Queensland, Australia

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Woodville South, South Australia, Australia

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Heidelberg West, Victoria, Australia

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Nedlands, Western Australia, Australia

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Toronto, Ontario, Canada

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Hôpital Broca-La Rochefoucauld

Paris, , France

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Belfast, , Ireland

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Saint Leonards-on-Sea, East Sussex, United Kingdom

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West End, Southampton, United Kingdom

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Swindon, Wilshire, United Kingdom

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Bath, , United Kingdom

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Blackpool, , United Kingdom

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Bradford, , United Kingdom

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Countries

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United States Australia Canada France Ireland United Kingdom

Other Identifiers

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E2020-A001-315

Identifier Type: -

Identifier Source: org_study_id

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