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NCT00151502 Clinical Trial

To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.

Alzheimer's Disease Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00151502
Other study ID # A2581078
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2002
Est. completion date July 2007

Study information
Verified date February 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date July 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 50 Years to 90 Years
Eligibility 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. 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

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin

Locations
Country Name City State
Australia Pfizer Investigational Site Ballarat Victoria
Australia Pfizer Investigational Site Daw Park South Australia
Australia Pfizer Investigational Site East Gosford New South Wales
Australia Pfizer Investigational Site Nedlands Western Australia
Australia Pfizer Investigational Site Randwick New South Wales
Australia Pfizer Investigational Site WEST Heidelberg Victoria
Australia Pfizer Investigational Site Woodville South South Australia
Austria Pfizer Investigational Site Wein
Austria Pfizer Investigational Site Wien
Austria Pfizer Investigational Site Wien
Canada Pfizer Investigational Site Calgary Alberta
Canada Pfizer Investigational Site Halifax Nova Scotia
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Vancouver British Columbia
Canada Pfizer Investigational Site Verdun Quebec
Denmark Pfizer Investigational Site Aarhus
Denmark Pfizer Investigational Site Copenhagen
Denmark Pfizer Investigational Site Hillerod
Denmark Pfizer Investigational Site Rudkobing
Denmark Pfizer Investigational Site Svendborg
Germany Pfizer Investigational Site Bad Honnef
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Bochum
Germany Pfizer Investigational Site Bonn
Germany Pfizer Investigational Site Goettingen
Germany Pfizer Investigational Site Hannover
Germany Pfizer Investigational Site Muenchen
Germany Pfizer Investigational Site Muenchen
Germany Pfizer Investigational Site Tuebingen
South Africa Pfizer Investigational Site Belleville
South Africa Pfizer Investigational Site Pinetown Kwazulu Natal
South Africa Pfizer Investigational Site Rosebank Gauteng
South Africa Pfizer Investigational Site Westville
South Africa Pfizer Investigational Site Willows Gauteng
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Terrassa Barcelona
Sweden Pfizer Investigational Site Linkoeping
Sweden Pfizer Investigational Site Malmoe
Sweden Pfizer Investigational Site Moelndal
Sweden Pfizer Investigational Site Stockholm
Sweden Pfizer Investigational Site Uddevalla
United Kingdom Pfizer Investigational Site Bath
United Kingdom Pfizer Investigational Site Belfast
United Kingdom Pfizer Investigational Site Bradford England
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Glasgow
United Kingdom Pfizer Investigational Site Penarth
United Kingdom Pfizer Investigational Site Southhampton
United Kingdom Pfizer Investigational Site Stirling
United Kingdom Pfizer Investigational Site Stirling Stirlingshire
United Kingdom Pfizer Investigational Site Swindon Wiltshire
United States Pfizer Investigational Site Albany New York
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Austin Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site East Providence Rhode Island
United States Pfizer Investigational Site Fort Lauderdale Florida
United States Pfizer Investigational Site Fort Myers Florida
United States Pfizer Investigational Site Fort Wayne Indiana
United States Pfizer Investigational Site Fresno California
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Jamesburg New Jersey
United States Pfizer Investigational Site Jenkintown Pennsylvania
United States Pfizer Investigational Site Kalamazoo Michigan
United States Pfizer Investigational Site Laguna Hills California
United States Pfizer Investigational Site Madison Tennessee
United States Pfizer Investigational Site Madison Wisconsin
United States Pfizer Investigational Site Miami Beach Florida
United States Pfizer Investigational Site Milwaukee Wisconsin
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Paducah Kentucky
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site Pompano Beach Florida
United States Pfizer Investigational Site Princeton New Jersey
United States Pfizer Investigational Site Providence Rhode Island
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Saint Petersburg Florida
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site South Dartmouth Massachusetts
United States Pfizer Investigational Site Sun City Arizona
United States Pfizer Investigational Site Troy New York
United States Pfizer Investigational Site Tulsa Oklahoma
United States Pfizer Investigational Site West Palm Beach Florida
United States Pfizer Investigational Site West Yarmouth Massachusetts
United States Pfizer Investigational Site Wichita Falls Texas
United States Pfizer Investigational Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  Denmark,  Germany,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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.
Secondary 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.
See also
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Completed NCT02256306 - The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study N/A
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Terminated NCT02220738 - Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors Phase 1
Completed NCT02309723 - How Beta-amyloid Imagining Influences Clinician Diagnosis and Management of Hypothetical Patients With Cognitive Complaints N/A

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