A MULTI-CENTER TRIAL OF SIMVASTATIN TO SLOW THE PROGRESSION OF ALZHEIMER'S DI

辛伐他汀减缓阿尔茨海默病 DI 进展的多中心试验

• 批准号: 7608290
• 负责人: KATHLEEN REDINGTON
• 金额: $ 0.29万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7608290
• 关键词: Alzheimer' s Disease; Computer Retrieval of Information on Scientific Projects Database; Double-Blind Method; Enrollment; Funding; Goals; Grant; Guidelines; Institution; Lipids; Outcome Measure; Patients; Pharmaceutical Preparations; Placebo Control; Placebos; Randomized; Research; Research Personnel; Resources; Safety; Simvastatin; Site; Source; United States National Institutes of Health; Week; design

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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目及 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 本研究的目的是评估辛伐他汀减缓阿尔茨海默病进展的安全性和有效性。 这是一种随机、双盲、安慰剂对照的平行组设计，药物和安慰剂的随机化程度相同。 将从大约 40 个站点招募 400 名受试者，目标是每个站点招募 10 至 15 名受试者。 受试者将是患有轻度至中度阿尔茨海默病的患者，根据目前的指南，他们不需要降脂治疗。 研究药物将按如下方式制备：在 6 周内给予 20 毫克辛伐他汀或匹配安慰剂，然后在剩余的 18 个月内给予 40 毫克辛伐他汀或匹配安慰剂。 主要结果指标将是 ADAScog 在 18 个月内的变化。