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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.600 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

600

Conditions

Alzheimer's Disease

Interventions

AtorvastatinDRUG

Eligibility

Sex: ALLMin age: 50 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (99)

Outcomes

Primary Outcomes

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

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.

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Sun City, Arizona, United States

Pfizer Investigational Site

Fresno, California, United States

Pfizer Investigational Site

Laguna Hills, California, United States

Pfizer Investigational Site

San Francisco, California, United States

Pfizer Investigational Site

Fort Lauderdale, Florida, United States

Pfizer Investigational Site

Fort Myers, Florida, United States

Pfizer Investigational Site

Miami Beach, Florida, United States

Pfizer Investigational Site

Pompano Beach, Florida, United States

Pfizer Investigational Site

St. Petersburg, Florida, United States

Pfizer Investigational Site

West Palm Beach, Florida, United States

...and 89 more locations