SIMVASTATIN TO SLOW THE PROGRESSION OF ALZHEIMER'S DISEASE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a clinical trial of simvastatin, an HMG CoA reductase inhibitor, the most commonly used class of lipid-lowering agents, to reduce the clinical progression of Alzheimer's disease. This is a placebo-controlled, parallel design study with two groups of equal size. The active daily treatment regimen will consist of simvastatin 20mg per day for 6 weeks followed by 40mg per day. Participants will be treated with this regimen for a total of 18 months with cognitive, behavioral, and clinical assessments every three months. The primary outcome measure is the rate of change in ADAScog score. Secondary outcome measures include ADCS-CGIC, Dependence Scale, ADCS-ADL, quality of lives and pharmacoeconomic scales, and the Neuropsychiatric Inventory. Additionally, blood will be drawn at the following visits: screening, 6-month, and 12-month for validation of a new instrument capable of better quantitating the efficacy of new drug protocols in AD clinical trials. This protocol is attached and included as a sub study to the current application, as not all sites will be participating. These blood samples will be used to determine the APP ratios, which may serve as a superior severity index in AD patients. The investigators hope that this assay can be used to measure improvements, or reduced cognitive declines, in groups of AD patients about to undergo a one-year blinded clinical trial with simvastatin vs. placebo.