Effect of Statins on Pathobiology of Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42
研究概览
简要总结
The purpose of this study is to see how simvastatin, a cholesterol-lowering drug, affects processes related to the development of Alzheimer's disease, including: 1) levels of a substance called beta-amyloid-42 found in the spinal fluid surrounding the brain, 2) blood flow in the brain, 3) inflammation in the brain, and 4) cognitive function.
详细描述
Some studies suggest that statin medications, which are a group of cholesterol-lowering medicines, may help prevent Alzheimer's disease. However, this has not been proven in humans. The purpose of this study is to see how simvastatin affects a substance in the spinal fluid around the brain called beta-amyloid-42 which is thought to contribute to Alzheimer's disease. This study also evaluates whether simvastatin improves regional brain blood flow (on magnetic resonance imaging [MRI]), reduces inflammation, and improves cognitive function.
The ESPRIT study was a 9-month randomized, controlled clinical trial that randomized 100 middle-aged adults with a parental history of Alzheimer's disease. Participants were randomized to simvastatin 40 mg for one month then 80 mg daily or matching placebo tablets. Fifty of the ESPRIT subjects participated in the MRI sub-study.
Participants had the following data collected: fasting blood tests (baseline and months 3 and 9), medical history and medication questionnaires (each visit), study medication side effect review (all visits), lumbar puncture procedure (baseline and month 9), memory testing (baseline and months 3 and 9), and MRI (baseline and month 9 in 50 sub-study participants).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 35 to 69
- •Parent with Alzheimer's disease
排除标准
- •Current use of cholesterol-lowering medication
- •Active liver disease
- •History of adverse reaction to statins
- •Contraindication to lumbar puncture
- •Elevated lab values (creatine kinase and creatinine)
- •Use of medications known to interact with statins
- •History of dementia
- •Currently pregnant or planning to become pregnant
- •Use of large quantities of grapefruit juice (more than 1 quart per day)
- •Current involvement in another investigational drug study
- •Contraindications to MRI (for MRI sub-study)
- •Ethical contraindication to placebo (persons with high vascular risk)
研究组 & 干预措施
simvastatin
simvastatin 40 mg nightly for 1 month then 80 mg nightly for 8 months
干预措施: Simvastatin (Drug)
Placebo
Matching placebo tablet nightly for 9 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42
时间窗: baseline and 9 months
次要结局
- Change in Inflammatory Markers(baseline and 9 months)
- Changes in Regional Cerebral Blood Flow on MRI(baseline and 9 months)
- Changes in Cognitive Performance(Baseline and 9 months)