SIMVASTATIN TO SLOW THE PROGRESSION OF ALZHEIMER'S DISEASE

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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物，用于减缓阿尔茨海默病的临床进展。 这是一项安慰剂对照的平行设计研究，两组大小相等。积极的每日治疗方案将包括辛伐他汀20 mg/d，连续6周，然后是40 mg/d。参与者将接受为期18个月的治疗，每三个月进行一次认知、行为和临床评估。 主要的结果衡量标准是ADAScog评分的变化率。次要结果测量包括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病学问卷。 此外，还将在以下检查中抽血：筛查、6个月和12个月，以验证新仪器的有效性，该仪器能够更好地量化AD临床试验中新药方案的疗效。由于并非所有站点都将参与，因此该方案作为子研究附加到当前应用程序中。这些血样将被用来确定APP比率，这可能作为AD患者的更好的严重程度指标。研究人员希望，这项测试可以用来衡量AD患者组的认知功能改善或减少，这些患者即将接受为期一年的辛伐他汀与安慰剂的盲法临床试验。

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.