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. Based on data accrued from observational and laboratory studies, the investigators hypothesize that simvastatin will significantly reduce the clinical progression of Alzheimer's disease (AD), as measured by ADAScog. They also hypothesize that those who use simvastatin will show beneficial effects over placebo on measures of activities of daily living, psychiatric and behavioral symptoms, quality of life and economic measures. To study these hypotheses, they will recruit a cohort of 400 subjects with AD who do not have hypercholesterolemia.
The aims of this study are as follows: to assess the safety and efficacy of simvastatin in the treatment of AD; to determine if there is an association between lowered lipid levels and clinical outcome measures in subjects with AD; to examine the influence of interaction of Apolipoprotein E (Apo E) genotype on the effect of simvastatin treatment on clinical outcome measures and lipid levels; and to determine whether treatment response is associated with other systemic markers of disease, including markers of amyloid and inflammation. This is a placebo-controlled, parallel-design study with two groups of equal size. The active daily treatment regimen will consist of simvastatin 20 mg/day for 6 weeks followed by 40 mg/day. Subjects will be treated with this regimen for a total of 18 months with cognitive, behavioral and clinical assessments at baseline and at 3, 6, 12, 18 and 20 months. Quality of life and pharmaco-economic assessments will be done at baseline, 6, 12, 18 and 20 months. The study is continuing to enroll subjects. No findings have been reported yet.
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