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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00151502
First received: September 6, 2005
Last updated: July 9, 2008
Last verified: July 2008
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: Atorvastatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 600
Study Start Date: November 2002
Study Completion Date: July 2007
  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151502

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, California
Pfizer Investigational Site
Fresno, California, United States, 93720
Pfizer Investigational Site
Laguna Hills, California, United States, 92653
Pfizer Investigational Site
San Francisco, California, United States, 94109
United States, Florida
Pfizer Investigational Site
Fort Lauderdale, Florida, United States, 33321
Pfizer Investigational Site
Fort Meyers, 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
St Petersburg, Florida, United States, 33702
Pfizer Investigational Site
West Palm Beach, Florida, United States, 33407
United States, Indiana
Pfizer Investigational Site
Fort Wayne, Indiana, United States, 46805
United States, Kentucky
Pfizer Investigational Site
Paducah, Kentucky, United States, 42003
United States, Louisiana
Pfizer Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
Pfizer Investigational Site
Dartmouth, Massachusetts, United States, 02747
Pfizer Investigational Site
W Yarmouth, Massachusetts, United States, 02673
Pfizer Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49048-1640
United States, New Jersey
Pfizer Investigational Site
Jamesburg, New Jersey, United States, 08831
Pfizer Investigational Site
Princeton, New Jersey, United States, 08540
United States, New Mexico
Pfizer Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Pfizer Investigational Site
Albany, New York, United States, 12208
Pfizer Investigational Site
Rochester, New York, United States, 14620
Pfizer Investigational Site
Troy, New York, United States, 12180
United States, Oklahoma
Pfizer Investigational Site
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Pfizer Investigational Site
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
United States, Rhode Island
Pfizer Investigational Site
East Providence, Rhode Island, United States, 02914
Pfizer Investigational Site
Providence, Rhode Island, United States, 02906
United States, Tennessee
Pfizer Investigational Site
Madison, Tennessee, United States, 37115
United States, Texas
Pfizer Investigational Site
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
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23294
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98108
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53705
Pfizer Investigational Site
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Pfizer Investigational Site
East Gosford, New South Wales, Australia, 2250
Pfizer Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Pfizer Investigational Site
Daw Park, South Australia, Australia, 5041
Pfizer Investigational Site
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Pfizer Investigational Site
Ballarat, Victoria, Australia, 3350
Pfizer Investigational Site
West Heidelberg, Victoria, Australia, 3081
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Austria
Pfizer Investigational Site
Wein, Austria, A-1130
Pfizer Investigational Site
Wien, Austria, A-1220
Pfizer Investigational Site
Wien, Austria, A-1030
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Nova Scotia
Pfizer Investigational Site
Halifax, Nova Scotia, Canada, B3H 2E1
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6C 5J1
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H1T 2M4
Pfizer Investigational Site
Montreal, Quebec, Canada, H3T 1E2
Pfizer Investigational Site
Verdun, Quebec, Canada, H4H-1R3
Canada
Pfizer Investigational Site
Quebec, Canada, G1J 1Z4
Denmark
Pfizer Investigational Site
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
Germany
Pfizer Investigational Site
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
South Africa
Pfizer Investigational Site
Rosebank, Gauteng, South Africa, 2196
Pfizer Investigational Site
Willows, Gauteng, South Africa, 0041
Pfizer Investigational Site
Pinetown, Kwazulu Natal, South Africa, 3600
Pfizer Investigational Site
Belleville, South Africa, 7530
Pfizer Investigational Site
Westville, South Africa, 3630
Spain
Pfizer Investigational Site
Terrassa, Barcelona, Spain, 08221
Pfizer Investigational Site
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
Sweden
Pfizer Investigational Site
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
United Kingdom
Pfizer Investigational Site
Bradford, England, United Kingdom, BD5 OBS
Pfizer Investigational Site
Stirling, Stirlingshire, United Kingdom, FK8 1PH
Pfizer Investigational Site
Swindon, Wiltshire, United Kingdom, SN1 4JU
Pfizer Investigational Site
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00151502     History of Changes
Other Study ID Numbers: A2581078
Study First Received: September 6, 2005
Last Updated: July 9, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Atorvastatin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014