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

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。 本研究的目的是评价辛伐他汀延缓阿尔茨海默病进展的安全性和有效性。这是一项随机、双盲、安慰剂对照、平行分组设计，与药物和安慰剂一样随机。将从大约40个地点招收400名受试者，每个地点的目标是10到15个受试者。受试者将是根据当前指南不需要降脂治疗的轻度至中度阿尔茨海默病患者。研究用药将准备如下：给予20毫克辛伐他汀或匹配的安慰剂，为期6周，随后给予40毫克的辛伐他汀或匹配的安慰剂，用于18个月的剩余时间。主要的结果衡量标准将是ADASCOG在18个月内的变化。

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.