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

Primary Purpose

Alzheimer's Disease, Dementia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Donepezil hydrochloride
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, dementia, acetylcholinesterase, donepezil, Aricept, memory loss, Severe dementia of the Alzheimer's type

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Broca-La Rochefoucauld

Outcomes

Primary Outcome Measures

Assessments of global and cognitive function of Severe AD patients

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2004
Last Updated
March 31, 2011
Sponsor
Eisai Inc.
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00096473
Brief Title
Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
January 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
September 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Inc.
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia
Keywords
Alzheimer's Disease, dementia, acetylcholinesterase, donepezil, Aricept, memory loss, Severe dementia of the Alzheimer's type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Donepezil hydrochloride
Primary Outcome Measure Information:
Title
Assessments of global and cognitive function of Severe AD patients
Secondary Outcome Measure Information:
Title
Assessment of behavior and performance on Activity of Daily Living in severe AD patients
Title
Assessment of caregiver burden

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Richardson, Ph.D.
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Honglan Li, Ph.D.
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
City
Northport
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Sun City
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Santa Monica
State/Province
California
Country
United States
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Torrance
State/Province
California
Country
United States
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Denver
State/Province
Colorado
Country
United States
City
Ft. Lauderdale
State/Province
Florida
Country
United States
City
Ft. Myers
State/Province
Florida
Country
United States
City
North Miami
State/Province
Florida
Country
United States
City
St. Petersburg
State/Province
Florida
Country
United States
City
Atlanta
State/Province
Georgia
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Long Branch
State/Province
New Jersey
Country
United States
City
Piscataway
State/Province
New Jersey
Country
United States
City
New Hyde Park
State/Province
New York
Country
United States
City
Greenville
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Centerville
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Jenkintown
State/Province
Pennsylvania
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Randwick
State/Province
New South Wales
Country
Australia
City
Brisbane
State/Province
Queensland
Country
Australia
City
Woodville South
State/Province
South Australia
Country
Australia
City
Heidelberg West
State/Province
Victoria
Country
Australia
City
Nedlands
State/Province
Western Australia
Country
Australia
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hôpital Broca-La Rochefoucauld
City
Paris
Country
France
City
Belfast
Country
Ireland
City
St. Leonards on Sea
State/Province
East Sussex
Country
United Kingdom
City
West End
State/Province
Southampton
Country
United Kingdom
City
Swindon
State/Province
Wilshire
Country
United Kingdom
City
Bath
Country
United Kingdom
City
Blackpool
Country
United Kingdom
City
Bradford
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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