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| Sponsor: | Eisai Inc. |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00096473 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease Dementia |
Drug: Donepezil hydrochloride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 350 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | June 2005 |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| 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 | |
| Torrance, California, United States | |
| San Francisco, California, United States | |
| Santa Monica, California, United States | |
| United States, Colorado | |
| Denver, Colorado, United States | |
| United States, Florida | |
| St. Petersburg, Florida, United States | |
| Ft. Lauderdale, Florida, United States | |
| Ft. Myers, Florida, United States | |
| North Miami, 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 | |
| Piscataway, New Jersey, United States | |
| Long Branch, New Jersey, United States | |
| United States, New York | |
| New Hyde Park, New York, United States | |
| United States, North Carolina | |
| Raleigh, North Carolina, United States | |
| Greenville, 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 | |
| Houston, Texas, United States | |
| Austin, 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 | |
| Ireland | |
| Belfast, Ireland | |
| United Kingdom | |
| Blackpool, United Kingdom | |
| Bath, United Kingdom | |
| Bradford, United Kingdom | |
| United Kingdom, East Sussex | |
| St. Leonards on Sea, East Sussex, United Kingdom | |
| United Kingdom, Southampton | |
| West End, Southampton, United Kingdom | |
| United Kingdom, Wilshire | |
| Swindon, Wilshire, United Kingdom | |
| Study Director: | Sharon Richardson, Ph.D. | Eisai Inc. |
| Study Director: | Honglan Li, Ph.D. | Eisai Inc. |
More Information
| Study ID Numbers: | E2020-A001-315 |
| Study First Received: | November 9, 2004 |
| Last Updated: | March 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00096473 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Alzheimer's Disease dementia acetylcholinesterase donepezil |
Aricept memory loss Severe dementia of the Alzheimer's type |
|
Nootropic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Brain Diseases |
Neurodegenerative Diseases Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Therapeutic Uses Donepezil Dementia Tauopathies Central Nervous System Agents |
