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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00096473
Recruitment Status : Completed
First Posted : November 10, 2004
Last Update Posted : April 1, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eisai Inc.

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Drug: Donepezil hydrochloride Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : January 2001
Actual Primary Completion Date : June 2005
Actual Study Completion Date : September 2005

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Assessments of global and cognitive function of Severe AD patients

Secondary Outcome Measures :
  1. Assessment of behavior and performance on Activity of Daily Living in severe AD patients
  2. Assessment of caregiver burden

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00096473


Locations
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United States, Alabama
Northport, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
United States, California
San Francisco, California, United States
Santa Monica, California, United States
Torrance, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Florida
Ft. Lauderdale, Florida, United States
Ft. Myers, Florida, United States
North Miami, Florida, United States
St. Petersburg, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, New Jersey
Long Branch, New Jersey, United States
Piscataway, New Jersey, United States
United States, New York
New Hyde Park, New York, United States
United States, North Carolina
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
United States, Ohio
Centerville, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Medford, Oregon, United States
Portland, Oregon, United States
United States, Pennsylvania
Jenkintown, Pennsylvania, United States
United States, Texas
Austin, Texas, United States
Houston, Texas, United States
Australia, New South Wales
Randwick, New South Wales, Australia
Australia, Queensland
Brisbane, Queensland, Australia
Australia, South Australia
Woodville South, South Australia, Australia
Australia, Victoria
Heidelberg West, Victoria, Australia
Australia, Western Australia
Nedlands, Western Australia, Australia
Canada, Ontario
Toronto, Ontario, Canada
France
Hôpital Broca-La Rochefoucauld
Paris, France
Ireland
Belfast, Ireland
United Kingdom
St. Leonards on Sea, East Sussex, United Kingdom
West End, Southampton, United Kingdom
Swindon, Wilshire, United Kingdom
Bath, United Kingdom
Blackpool, United Kingdom
Bradford, United Kingdom
Sponsors and Collaborators
Eisai Inc.
Pfizer
Investigators
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Study Director: Sharon Richardson, Ph.D. Eisai Inc.
Study Director: Honglan Li, Ph.D. Eisai Inc.
More Information
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ClinicalTrials.gov Identifier: NCT00096473    
Other Study ID Numbers: E2020-A001-315
First Posted: November 10, 2004    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011
Keywords provided by Eisai Inc.:
Alzheimer's Disease
dementia
acetylcholinesterase
donepezil
 Aricept
memory loss
Severe dementia of the Alzheimer's type
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
 Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents