Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 341
- 试验地点
- 2
- 主要终点
- Free water
研究概览
简要总结
The STAREE-Mind imaging sub-study will examine the effect of statin treatment over a 4-year period, compared with placebo, on markers of brain health.
详细描述
STAREE-Mind imaging is a sub-study nested in the Statins in Reducing Events in the Elderly (STAREE) double blind randomised placebo-controlled trial. STAREE is investigating whether statins can prolong good health and maintain independence amongst older people and is enrolling. STAREE-Mind imaging aims to recruit a sub-group of 340 participants, and will involve an additional suite of brain imaging in these participants, at recruitment (before medication is commenced) and at 4 years follow-up. It will provide crucial information about the clinical effects of statins on brain health in older individuals.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants in the STAREE RCT and eligible for randomisation to study medication.
- •Men and women
- •Aged ≥70 years
- •Living independently in the community
- •Willing and able to provide informed consent and agree to participate in brain neuroimaging.
- •Able to attend one of the 2 sites (in Melbourne and Brisbane) where the imaging will take place.
排除标准
- •Contraindications to have magnetic resonance neuroimaging performed.
- •History of invasive brain surgery or known structural bran abnormalities.
研究组 & 干预措施
STAREE Statin group
干预措施: Atorvastatin 40 Mg Oral Tablet (Drug)
STAREE Placebo group
干预措施: Placebo (Drug)
结局指标
主要结局
Free water
时间窗: Change from baseline to four years
Multi-compartment free water quantitation from brain diffusion-weighted MRI
White matter hyperintensity volume
时间窗: Change from baseline to four years
From brain FLAIR MRI
次要结局
未报告次要终点