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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

The purpose of this study is to find out if atovastatin, when taken with a cholinesterase inhibitor, is effective for treating Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • East Gosford, New South Wales, Australia, 2250
        • Pfizer Investigational Site
      • Randwick, New South Wales, Australia, 2031
        • Pfizer Investigational Site
    • South Australia
      • Daw Park, South Australia, Australia, 5041
        • Pfizer Investigational Site
      • Woodville South, South Australia, Australia, 5011
        • Pfizer Investigational Site
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Pfizer Investigational Site
      • WEST Heidelberg, Victoria, Australia, 3081
        • Pfizer Investigational Site
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Pfizer Investigational Site
  • Austria
      • Wein, Austria, A-1130
        • Pfizer Investigational Site
      • Wien, Austria, A-1030
        • Pfizer Investigational Site
      • Wien, Austria, A-1220
        • Pfizer Investigational Site
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Pfizer Investigational Site
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • Pfizer Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Pfizer Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2E1
        • Pfizer Investigational Site
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
      • Verdun, Quebec, Canada, H4H-1R3
        • Pfizer Investigational Site
  • Denmark
      • Aarhus, Denmark, 8000
        • Pfizer Investigational Site
      • Copenhagen, Denmark, 2100
        • Pfizer Investigational Site
      • Hillerod, Denmark, 3400
        • Pfizer Investigational Site
      • Rudkobing, Denmark, 5900
        • Pfizer Investigational Site
      • Svendborg, Denmark, 5700
        • Pfizer Investigational Site
  • Germany
      • Bad Honnef, Germany, 53604
        • Pfizer Investigational Site
      • Berlin, Germany, 13347
        • Pfizer Investigational Site
      • Bochum, Germany, D-44892
        • Pfizer Investigational Site
      • Bonn, Germany, 53105
        • Pfizer Investigational Site
      • Goettingen, Germany, 37073
        • Pfizer Investigational Site
      • Hannover, Germany, 30559
        • Pfizer Investigational Site
      • Muenchen, Germany, 80336
        • Pfizer Investigational Site
      • Muenchen, Germany, 81675
        • Pfizer Investigational Site
      • Tuebingen, Germany, 72076
        • Pfizer Investigational Site
  • South Africa
      • Belleville, South Africa, 7530
        • Pfizer Investigational Site
      • Westville, South Africa, 3630
        • Pfizer Investigational Site
    • Gauteng
      • Rosebank, Gauteng, South Africa, 2196
        • Pfizer Investigational Site
      • Willows, Gauteng, South Africa, 0041
        • Pfizer Investigational Site
    • Kwazulu Natal
      • Pinetown, Kwazulu Natal, South Africa, 3600
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Pfizer Investigational Site
      • Barcelona, Spain, 08003
        • Pfizer Investigational Site
      • Barcelona, Spain, 08014
        • Pfizer Investigational Site
      • Madrid, Spain, 28050
        • Pfizer Investigational Site
      • Madrid, Spain, 28046
        • Pfizer Investigational Site
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Pfizer Investigational Site
  • Sweden
      • Linkoeping, Sweden, SE-58185
        • Pfizer Investigational Site
      • Malmoe, Sweden, SE-20502
        • Pfizer Investigational Site
      • Moelndal, Sweden, SE-43180
        • Pfizer Investigational Site
      • Stockholm, Sweden, 18146
        • Pfizer Investigational Site
      • Uddevalla, Sweden, SE-45180
        • Pfizer Investigational Site
  • United Kingdom
      • Bath, United Kingdom, BA2 5RP
        • Pfizer Investigational Site
      • Belfast, United Kingdom, BT9 7BL
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G51 4TF
        • Pfizer Investigational Site
      • Glasgow, United Kingdom, G20 0XA
        • Pfizer Investigational Site
      • Penarth, United Kingdom, CF642XX
        • Pfizer Investigational Site
      • Southhampton, United Kingdom, SO30 3JB
        • Pfizer Investigational Site
      • Stirling, United Kingdom, FK8 1RW
        • Pfizer Investigational Site
    • England
      • Bradford, England, United Kingdom, BD5 OBS
        • Pfizer Investigational Site
    • Stirlingshire
      • Stirling, Stirlingshire, United Kingdom, FK8 1PH
        • Pfizer Investigational Site
    • Wiltshire
      • Swindon, Wiltshire, United Kingdom, SN1 4JU
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Pfizer Investigational Site
    • California
      • Fresno, California, United States, 93720
        • Pfizer Investigational Site
      • Laguna Hills, California, United States, 92653
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94109
        • Pfizer Investigational Site
    • Florida
      • Fort Lauderdale, Florida, United States, 33321
        • Pfizer Investigational Site
      • Fort Myers, Florida, United States, 33912
        • Pfizer Investigational Site
      • Miami Beach, Florida, United States, 33154
        • Pfizer Investigational Site
      • Pompano Beach, Florida, United States, 33064
        • Pfizer Investigational Site
      • Saint Petersburg, Florida, United States, 33702
        • Pfizer Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Pfizer Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Pfizer Investigational Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Pfizer Investigational Site
    • Massachusetts
      • South Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
      • West Yarmouth, Massachusetts, United States, 02673
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49048-1640
        • Pfizer Investigational Site
    • New Jersey
      • Jamesburg, New Jersey, United States, 08831
        • Pfizer Investigational Site
      • Princeton, New Jersey, United States, 08540
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pfizer Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14620
        • Pfizer Investigational Site
      • Troy, New York, United States, 12180
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Pfizer Investigational Site
      • Allentown, Pennsylvania, United States, 18013
        • Pfizer Investigational Site
      • Jenkintown, Pennsylvania, United States, 19046
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15205
        • Pfizer Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Pfizer Investigational Site
      • Providence, Rhode Island, United States, 02906
        • Pfizer Investigational Site
    • Tennessee
      • Madison, Tennessee, United States, 37115
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, United States, 78756-3433
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75235
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Wichita Falls, Texas, United States, 76309
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98108
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, United States, 53226
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2002

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

September 6, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2581078

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Costa Rica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe