A TRIAL OF SIMVASTATIN TO SLOW THE PROGRESSION OF ALZHEIMER'S DISEASE

辛伐他汀减缓阿尔茨海默病进展的试验

• 批准号: 7378285
• 负责人: STEVEN H FERRIS
• 金额: $ 0.09万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7378285
• 关键词: TRIAL; SIMVASTATIN; SLOW; PROGRESSION; ALZHEIMER

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. Based on data accrued from observational and laboratory studies, the investigators hypothesize that simvastatin will significantly reduce the clinical progression of Alzheimer's disease (AD), as measured by ADAScog. They also hypothesize that those who use simvastatin will show beneficial effects over placebo on measures of activities of daily living, psychiatric and behavioral symptoms, quality of life and economic measures. To study these hypotheses, they will recruit a cohort of 400 subjects with AD who do not have hypercholesterolemia. The aims of this study are as follows: to assess the safety and efficacy of simvastatin in the treatment of AD; to determine if there is an association between lowered lipid levels and clinical outcome measures in subjects with AD; to examine the influence of interaction of Apolipoprotein E (Apo E) genotype on the effect of simvastatin treatment on clinical outcome measures and lipid levels; and to determine whether treatment response is associated with other systemic markers of disease, including markers of amyloid and inflammation. This is a placebo-controlled, parallel-design study with two groups of equal size. The active daily treatment regimen will consist of simvastatin 20 mg/day for 6 weeks followed by 40 mg/day. Subjects will be treated with this regimen for a total of 18 months with cognitive, behavioral and clinical assessments at baseline and at 3, 6, 12, 18 and 20 months. Quality of life and pharmaco-economic assessments will be done at baseline, 6, 12, 18 and 20 months. The study is continuing to enroll subjects. No findings have been reported yet.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。根据观察性和实验室研究积累的数据，研究人员假设辛伐他汀将显著减少ADAScog测量的阿尔茨海默病（AD）的临床进展。他们还假设，在日常生活活动、精神和行为症状、生活质量和经济指标方面，使用辛伐他汀的患者将比安慰剂表现出有益的效果。为了研究这些假设，他们将招募400名没有高胆固醇血症的AD患者。本研究的目的是：评价辛伐他汀治疗AD的安全性和有效性；确定AD患者血脂水平降低与临床预后指标之间是否存在关联；研究载脂蛋白E （Apo E）基因型相互作用对辛伐他汀治疗对临床结局指标和血脂水平的影响；并确定治疗反应是否与其他系统性疾病标志物有关，包括淀粉样蛋白和炎症标志物。这是一项安慰剂对照、平行设计的研究，两组人数相等。积极的每日治疗方案将包括辛伐他汀20mg /天，持续6周，然后是40mg /天。受试者将接受该方案共计18个月的治疗，并在基线和3、6、12、18和20个月时进行认知、行为和临床评估。生活质量和药物经济学评估将在基线、6、12、18和20个月进行。该研究仍在继续招募受试者。目前还没有发现报告。