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SIMVASTATIN TO SLOW THE PROGRESSION OF ALZHEIMER'S DISEASE

Background
Labaratory research and clinical trials have shown that lowering cholesterol may reduce the pathology of Alzheimer's disease. This clinical trial of simvastatin, a lipid lowering agent, will focus on reducing the clinical progression of Alzheimer's disease.

What is the primary outcome?
Slowing progression of Alzheimer's disease as measured by the cognitive portion of the Alzheimer’s Disease Assessment Scale (ADAScog).

What are the secondary outcomes?
Measures of clinical global change (ADCS-CGIC), mental status, functional ability, behavioral disturbances, quality of life and economic indicators.

How will this study be conducted?
This is a randomized, double-blind, placebo-controlled, parallel group design with equal randomization to drug and placebo. Randomization will be stratified and blocked to insure balanced assignment within site.

How many patients will be involved in this study?
A total of 400 patients will be recruited for the study with 15 patients from USC.

Who is eligible to participate in this study?
Mild to moderate patients with Alzheimer's disease who are free of life threatening disease and who do not require lipid lowering treatment according to current guidelines.

How will the study medications be administered?
Study medication will be prepared as follows: 20 mg of simvastatin or matching placebo will be given for a period of 6 weeks followed by 40 mg of simvastatin or matching placebo for the remainder of 18 months.

What is the primary efficacy measure?
Change on the ADAS-cog over 18 months.

What are the secondary efficacy measures?
Eighteen-month change on the ADCS Clinical Global Impression of Change (ADCS-CGIC), the Mini-Mental State Examination (MMSE), the Dependence Scale, the ADCS Activities of Daily Living (ADCS-ADL) scale, the Neuropsychiatric Inventory (NPI), Quality of Life and Pharmaco-economic Measure. Biomarkers of amyloid, inflammation and oxidative stress will also be examined from stored samples in a subset of subjects. Apolipoprotein E and other markers will also be collected for secondary analysis.

How can I enroll in this study?
This study is currently enrolling volunteers. If interested, please contact:
Morella Menicucci or Shirley Sian
University of Southern California Keck School of Medicine
(323) 442-7600
e-mail: sian@usc.edu