Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00096473




Registration number
NCT00096473
Ethics application status
Date submitted
9/11/2004
Date registered
10/11/2004
Date last updated
1/04/2011

Titles & IDs
Public title
Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
Scientific 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
Secondary ID [1] 0 0
E2020-A001-315
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Dementia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Assessments of global and cognitive function of Severe AD patients
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Assessment of behavior and performance on Activity of Daily Living in severe AD patients
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Assessment of caregiver burden
Timepoint [2] 0 0

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2005
Sample size
Target
Accrual to date
Final
229
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Randwick
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Woodville South
Recruitment hospital [4] 0 0
- Heidelberg West
Recruitment hospital [5] 0 0
- Nedlands
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Woodville South
Recruitment postcode(s) [4] 0 0
- Heidelberg West
Recruitment postcode(s) [5] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oklahoma
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
France
State/province [19] 0 0
Paris
Country [20] 0 0
Ireland
State/province [20] 0 0
Belfast
Country [21] 0 0
United Kingdom
State/province [21] 0 0
East Sussex
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Southampton
Country [23] 0 0
United Kingdom
State/province [23] 0 0
Wilshire
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Bath
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Blackpool
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Bradford

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eisai Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00096473
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sharon Richardson, Ph.D.
Address 0 0
Eisai Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00096473