Impact of Atorvastatin on Cerebral Perfusion and Endothelial Function
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
- 是
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
40mg Atorvastatin nightly for 4 months
干预措施: atorvastatin (Drug)
Placebo
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)
