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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00151502




Registration number
NCT00151502
Ethics application status
Date submitted
6/09/2005
Date registered
9/09/2005
Date last updated
18/02/2021

Titles & IDs
Public title
To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.
Scientific title
An 80-Week, Randomized, Multi-Center, Parallel-Group, Double-Blind Study of the Efficacy and Safety of Atorvastatin 80 MG Plus an Acetylcholinesterase Inhibitor Versus an Acetylcholinesterase Inhibitor Alone in the Treatment of Mild to Moderate Alzheimer's Disease.
Secondary ID [1] 0 0
A2581078
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 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
If the results of this study demonstrate efficacy and lead to the approval by the FDA of atorvastatin for use in humans for the treatment of Alzheimer's disease, this would be available as an additional treatment option for patients.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
If the results of this study demonstrate efficacy and lead to the approval by the Food and Drug Administration of atorvastatin for use in humans, subject activities of daily living are being assessed.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Diagnostic evidence of probable Alzheimer's disease consistent with NINCDS/ADRDA and DSM IV criteria.
* Subject's Mini-Mental Status Examination Score (MMSE) must be in the range of 13 - 25 (inclusive) at Screening.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects with dementia due to causes other than Alzheimer's disease.
* Any condition, which, in the investigator's judgment might increase the risk to the subject or decrease the reliability of the data required to meet the objectives of the study.

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
1/11/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - East Gosford
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Randwick
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Daw Park
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Woodville South
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Ballarat
Recruitment hospital [6] 0 0
Pfizer Investigational Site - WEST Heidelberg
Recruitment hospital [7] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - East Gosford
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
5041 - Daw Park
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3350 - Ballarat
Recruitment postcode(s) [6] 0 0
3081 - WEST Heidelberg
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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Florida
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United States of America
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Indiana
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Kentucky
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Louisiana
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Massachusetts
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Michigan
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New Jersey
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New Mexico
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New York
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Oklahoma
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Pennsylvania
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Rhode Island
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Tennessee
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Texas
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Virginia
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Washington
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Wisconsin
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Austria
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Wein
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Austria
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Wien
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Denmark
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Aarhus
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Denmark
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Copenhagen
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Denmark
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Hillerod
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Denmark
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Rudkobing
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Denmark
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Svendborg
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Germany
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Bad Honnef
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Goettingen
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Germany
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Hannover
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Germany
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Muenchen
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Germany
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Tuebingen
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South Africa
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Gauteng
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South Africa
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Kwazulu Natal
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South Africa
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Belleville
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South Africa
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Westville
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Spain
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Barcelona
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Spain
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Madrid
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Sweden
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Linkoeping
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Sweden
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Malmoe
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Sweden
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Moelndal
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Stockholm
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Sweden
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Uddevalla
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United Kingdom
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England
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Stirlingshire
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Wiltshire
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Bath
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Belfast
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Glasgow
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Penarth
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Southhampton
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United Kingdom
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Stirling

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to find out if atovastatin, when taken with a cholinesterase inhibitor, is effective for treating Alzheimer's disease.
Trial website
https://clinicaltrials.gov/study/NCT00151502
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
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/NCT00151502