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临床试验/NCT00751907
NCT00751907已完成2 期

Impact of Atorvastatin on Cerebral Perfusion and Endothelial Function

University of Wisconsin, Madison1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2006年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
16
试验地点
1
主要终点
Change in regional cerebral blood flow (rCBF)

研究概览

简要总结

The purpose of this study is to evaluate the hypothesis that in middle-aged, asymptomatic, adult children of persons with Alzheimer's disease (AD), atorvastatin therapy will beneficially affect mechanisms thought to contribute to AD risk by improving blood flow in the brain, improving cerebral perfusion, increasing brain activity patterns, and improving blood vessel function.

详细描述

Treatment with cholesterol-lowering medications, specifically statins, is associated with up to a 73% reduction in the prevalence of AD, suggesting a potentially promising role for statins in the prevention of AD. In order to better understand the mechanisms through which statins may possibly modify blood AD risk, this study evaluated whether administration of atorvastatin favorably altered blood flow in the brain (measured by magnetic resonance imaging (MRI)) and blood vessel function (measured by ultrasound).

Participants attended 3 visits over the course of the 4-month study. At the initial visit, participants completed a short questionnaire about their past medical history and medication history. At the baseline visit, participants were randomized in a 1:1 ratio to receive atorvastatin 40 mg nightly vs. matching placebo. At baseline and follow-up visits, participants provided an update on medical problems and medications, reviewed any potential side effects, and had fasting blood tests collected for safety monitoring, including liver and muscle enzyme monitoring. In addition, all participants had MRI and ultrasound measures collected.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (ages 40-65) children of parent with documented Alzheimer's disease

排除标准

  • Current use of cholesterol lowering medication
  • History of liver disease
  • History of adverse reaction to statin medications
  • Elevated lab values (CK and creatinine)
  • Use of medications that counteract with atorvastatin
  • History of dementia
  • Currently pregnant
  • Use of large quantities of grapefruit juice (more than 1 quart/day)
  • Current involvement in another investigational drug study
  • Contraindications to MRI

研究组 & 干预措施

Atorvastatin

Experimental

40mg Atorvastatin nightly for 4 months

干预措施: atorvastatin (Drug)

Placebo

Placebo Comparator

matching placebo nightly for 4 months

干预措施: Placebo (Drug)

结局指标

主要结局

Change in regional cerebral blood flow (rCBF)

时间窗: Baseline and 4 months

rCBF , a measure of cerebral perfusion, is the primary outcome. rCBF was measured by arterial spin-labeling magnetic resonance imaging and used to evaluate effects of atorvastatin vs placebo

次要结局

  • Change in Endothelial function(Baseline and 4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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