Clinical trial NCT00096473: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Dementia
Keywords: Alzheimer's Disease
dementia
acetylcholinesterase
donepezil
Aricept
memory loss
Severe dementia of the Alzheimer's type
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2004-11-10
Enrollment: 229
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Assessments of global and cognitive function of Severe AD patients
Secondary outcomes:
measure: Assessment of behavior and performance on Activity of Daily Living in severe AD patients
measure: Assessment of caregiver burden
Other outcomes:
Locations:
city: Northport
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Sun City
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: San Francisco
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Torrance
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Ft. Lauderdale
country: United States
state: Florida
city: Ft. Myers
country: United States
state: Florida
city: North Miami
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: New Orleans
country: United States
state: Louisiana
city: Springfield
country: United States
state: Massachusetts
city: Long Branch
country: United States
state: New Jersey
city: Piscataway
country: United States
state: New Jersey
city: New Hyde Park
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Centerville
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Medford
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Jenkintown
country: United States
state: Pennsylvania
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Randwick
country: Australia
state: New South Wales
city: Brisbane
country: Australia
state: Queensland
city: Woodville South
country: Australia
state: South Australia
city: Heidelberg West
country: Australia
state: Victoria
city: Nedlands
country: Australia
state: Western Australia
city: Toronto
country: Canada
state: Ontario
city: Paris
country: France
facility: Hôpital Broca-La Rochefoucauld
city: Belfast
country: Ireland
city: St. Leonards on Sea
country: United Kingdom
state: East Sussex
city: West End
country: United Kingdom
state: Southampton
city: Swindon
country: United Kingdom
state: Wilshire
city: Bath
country: United Kingdom
city: Blackpool
country: United Kingdom
city: Bradford
country: United Kingdom
Study officials:
affiliation: Eisai Inc.
name: Sharon Richardson, Ph.D.
role: STUDY_DIRECTOR
affiliation: Eisai Inc.
name: Honglan Li, Ph.D.
role: STUDY_DIRECTOR
References: