CLINICAL TRIAL: A MULTI-CENTER TRIAL OF SIMVASTATIN TO SLOW THE PROGRESSION OF A

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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. The objective of this study is to evaluate the safety and efficacy of simvastatin to slow the progression of Alzheimer's disease. This is a randomized, double-blind, placebo-controlled, parallel group design with equal randomization to drug and placebo. 400 subjects will be enrolled from approximately 40 sites with a goal of 10 to 15 subjects enrolled at each site. Subjects will be patients with mild to moderate Alzheimer's disease who do not require lipid lowering treatment according to current guidelines. 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 the 18 months. The primary outcome measure will be change on the ADAScog over 18 months.