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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00096473