Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
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
1 other identifier
interventional
229
6 countries
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2001
Longer than P75 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2001
CompletedFirst Submitted
Initial submission to the registry
November 9, 2004
CompletedFirst Posted
Study publicly available on registry
November 10, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2005
CompletedApril 1, 2011
March 1, 2011
4.4 years
November 9, 2004
March 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessments of global and cognitive function of Severe AD patients
Secondary Outcomes (2)
Assessment of behavior and performance on Activity of Daily Living in severe AD patients
Assessment of caregiver burden
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any primary neurological or psychiatric diagnosis (including depressive disorder) other than Alzheimer's Disease
- Dementia caused by organic diseases other than Alzheimer's Disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
- Pfizercollaborator
Study Sites (42)
Unknown Facility
Northport, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
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
Unknown Facility
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
Hôpital Broca-La Rochefoucauld
Paris, France
Unknown Facility
Belfast, Ireland
Unknown Facility
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
Unknown Facility
Blackpool, United Kingdom
Unknown Facility
Bradford, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sharon Richardson, Ph.D.
Eisai Inc.
- STUDY DIRECTOR
Honglan Li, Ph.D.
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 9, 2004
First Posted
November 10, 2004
Study Start
January 1, 2001
Primary Completion
June 1, 2005
Study Completion
September 1, 2005
Last Updated
April 1, 2011
Record last verified: 2011-03