Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Outcome Measures
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 []
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northport | Alabama | United States | ||
| 2 | Phoenix | Arizona | United States | ||
| 3 | Sun City | Arizona | United States | ||
| 4 | Tucson | Arizona | United States | ||
| 5 | San Francisco | California | United States | ||
| 6 | Santa Monica | California | United States | ||
| 7 | Torrance | California | United States | ||
| 8 | Denver | Colorado | United States | ||
| 9 | Ft. Lauderdale | Florida | United States | ||
| 10 | Ft. Myers | Florida | United States | ||
| 11 | North Miami | Florida | United States | ||
| 12 | St. Petersburg | Florida | United States | ||
| 13 | Atlanta | Georgia | United States | ||
| 14 | Chicago | Illinois | United States | ||
| 15 | New Orleans | Louisiana | United States | ||
| 16 | Springfield | Massachusetts | United States | ||
| 17 | Long Branch | New Jersey | United States | ||
| 18 | Piscataway | New Jersey | United States | ||
| 19 | New Hyde Park | New York | United States | ||
| 20 | Greenville | North Carolina | United States | ||
| 21 | Raleigh | North Carolina | United States | ||
| 22 | Centerville | Ohio | United States | ||
| 23 | Oklahoma City | Oklahoma | United States | ||
| 24 | Medford | Oregon | United States | ||
| 25 | Portland | Oregon | United States | ||
| 26 | Jenkintown | Pennsylvania | United States | ||
| 27 | Austin | Texas | United States | ||
| 28 | Houston | Texas | United States | ||
| 29 | Randwick | New South Wales | Australia | ||
| 30 | Brisbane | Queensland | Australia | ||
| 31 | Woodville South | South Australia | Australia | ||
| 32 | Heidelberg West | Victoria | Australia | ||
| 33 | Nedlands | Western Australia | Australia | ||
| 34 | Toronto | Ontario | Canada | ||
| 35 | Hôpital Broca-La Rochefoucauld | Paris | France | ||
| 36 | Belfast | Ireland | |||
| 37 | St. Leonards on Sea | East Sussex | United Kingdom | ||
| 38 | West End | Southampton | United Kingdom | ||
| 39 | Swindon | Wilshire | United Kingdom | ||
| 40 | Bath | United Kingdom | |||
| 41 | Blackpool | United Kingdom | |||
| 42 | Bradford | United Kingdom |
Sponsors and Collaborators
- Eisai Inc.
- Pfizer
Investigators
- Study Director: Sharon Richardson, Ph.D., Eisai Inc.
- Study Director: Honglan Li, Ph.D., Eisai Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E2020-A001-315