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

NCT00151502 | Completed Phase 3

• 1 other identifier: A2581078
• Study Type: interventional
• Target: 600
• Locations: 9 countries
• Sites: 92

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Atorvastatin DRUG

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (99)

Pfizer Investigational Site

Sun City, Arizona, 85351, United States

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Fresno, California, 93720, United States

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Laguna Hills, California, 92653, United States

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San Francisco, California, 94109, United States

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Fort Lauderdale, Florida, 33321, United States

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Fort Myers, Florida, 33912, United States

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Miami Beach, Florida, 33154, United States

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Pompano Beach, Florida, 33064, United States

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St. Petersburg, Florida, 33702, United States

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West Palm Beach, Florida, 33407, United States

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Fort Wayne, Indiana, 46805, United States

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Paducah, Kentucky, 42003, United States

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New Orleans, Louisiana, 70112, United States

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South Dartmouth, Massachusetts, 02747, United States

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West Yarmouth, Massachusetts, 02673, United States

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Worcester, Massachusetts, 01655, United States

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Kalamazoo, Michigan, 49048-1640, United States

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Jamesburg, New Jersey, 08831, United States

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Princeton, New Jersey, 08540, United States

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Albuquerque, New Mexico, 87102, United States

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Albany, New York, 12208, United States

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Rochester, New York, 14620, United States

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Troy, New York, 12180, United States

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Tulsa, Oklahoma, 74104, United States

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Allentown, Pennsylvania, 18013, United States

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Allentown, Pennsylvania, 18103, United States

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Jenkintown, Pennsylvania, 19046, United States

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Pittsburgh, Pennsylvania, 15205, United States

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Pittsburgh, Pennsylvania, 15213, United States

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East Providence, Rhode Island, 02914, United States

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Providence, Rhode Island, 02906, United States

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Madison, Tennessee, 37115, United States

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Austin, Texas, 78756-3433, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77030, United States

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Wichita Falls, Texas, 76309, United States

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Richmond, Virginia, 23294, United States

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Seattle, Washington, 98108, United States

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Madison, Wisconsin, 53705, United States

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Milwaukee, Wisconsin, 53226, United States

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East Gosford, New South Wales, 2250, Australia

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Randwick, New South Wales, 2031, Australia

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Daw Park, South Australia, 5041, Australia

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Woodville South, South Australia, 5011, Australia

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Ballarat, Victoria, 3350, Australia

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WEST Heidelberg, Victoria, 3081, Australia

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Nedlands, Western Australia, 6009, Australia

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Vienna, A-1030, Austria

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Vienna, A-1220, Austria

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Wein, A-1130, Austria

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Calgary, Alberta, T2N 4N1, Canada

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Vancouver, British Columbia, V6T 2B5, Canada

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Halifax, Nova Scotia, B3H 2E1, Canada

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London, Ontario, N6C 5J1, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Québec, Quebec, G1J 1Z4, Canada

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Verdun, Quebec, H4H-1R3, Canada

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Aarhus, 8000, Denmark

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Copenhagen, 2100, Denmark

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Hillerød, 3400, Denmark

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Rudkøbing, 5900, Denmark

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Svendborg, 5700, Denmark

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Bad Honnef, 53604, Germany

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Berlin, 13347, Germany

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Bochum, D-44892, Germany

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Bonn, 53105, Germany

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Göttingen, 37073, Germany

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Hanover, 30559, Germany

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München, 80336, Germany

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München, 81675, Germany

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Tübingen, 72076, Germany

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Rosebank, Gauteng, 2196, South Africa

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Willows, Gauteng, 0041, South Africa

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Pinetown, KwaZulu-Natal, 3600, South Africa

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Belleville, 7530, South Africa

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Westville, 3630, South Africa

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Terrassa, Barcelona, 08221, Spain

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Barcelona, 08003, Spain

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Barcelona, 08014, Spain

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Barcelona, 08036, Spain

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Madrid, 28046, Spain

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Madrid, 28050, Spain

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Linköping, SE-58185, Sweden

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Malmo, SE-20502, Sweden

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Mölndal, SE-43180, Sweden

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Stockholm, 18146, Sweden

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Uddevalla, SE-45180, Sweden

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Bradford, England, BD5 OBS, United Kingdom

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Stirling, Stirlingshire, FK8 1PH, United Kingdom

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Swindon, Wiltshire, SN1 4JU, United Kingdom

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Bath, BA2 5RP, United Kingdom

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Belfast, BT9 7BL, United Kingdom

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Glasgow, G20 0XA, United Kingdom

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Glasgow, G51 4TF, United Kingdom

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Penarth, CF642XX, United Kingdom

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Southhampton, SO30 3JB, United Kingdom

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Stirling, FK8 1RW, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 9, 2005
• Study Start: November 1, 2002
• Study Completion: July 1, 2007
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

CA (9); DE (9); SE (5); AU (3); US (40); DK (5); ZA (5); ES (6); GB (10)