SIMVASTATIN TO SLOW THE PROGRESSION OF ALZHEIMER'S DISEASE

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这是一项辛伐他汀的临床试验，辛伐他汀是一种HMG CoA还原酶抑制剂，是最常用的一类降脂药，可减少阿尔茨海默病的临床进展。 这是一项安慰剂对照、平行设计研究，两组患者规模相同。 活性每日治疗方案包括辛伐他汀20 mg/天，持续6周，随后为40 mg/天。 参与者将接受总共18个月的该方案治疗，每三个月进行一次认知、行为和临床评估。 主要结局指标是ADAScog评分的变化率。 次要结局指标包括ADCS-CGIC、依赖量表、ADCS-ADL、生活质量和药物经济学量表以及神经精神量表。 此外，将在以下访视时采集血液：筛选、6个月和12个月，以验证能够更好地定量AD临床试验中新药方案疗效的新仪器。 本方案随附并作为子研究纳入当前申请，因为并非所有研究中心都将参与。 这些血液样本将用于确定APP比率，其可作为AD患者的上级严重程度指数。 研究人员希望，这种检测方法可以用来衡量改善，或减少认知能力下降，在一组AD患者即将接受为期一年的盲法临床试验辛伐他汀与安慰剂。

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.