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: 7376128
• 负责人: KATHLEEN REDINGTON
• 金额: $ 0.46万
• 依托单位: CHILDREN'S RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376128
• 关键词: MULTI; CENTER; TRIAL; SIMVASTATIN; SLOW

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NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。本研究的目的是评估辛伐他汀延缓阿尔茨海默病进展的安全性和有效性。这是一项随机化、双盲、安慰剂对照、平行组设计，药物和安慰剂的随机化程度相同。将从大约40家临床试验机构入组400例受试者，每家临床试验机构目标入组10 - 15例受试者。受试者将是根据现行指南不需要降脂治疗的轻度至中度阿尔茨海默病患者。研究药物制备如下：20 mg辛伐他汀或匹配安慰剂给药6周，随后40 mg辛伐他汀或匹配安慰剂给药18个月的剩余时间。主要结局指标将是18个月内ADAScog的变化。