Atorvastatin Mitigates WMH-Related Cognitive Impairment by Reducing VCAM-1: A Randomized, Double-Blind, Placebo-Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 401
- 试验地点
- 1
- 主要终点
- VACM1 levels at 0.5, 1.0, 1.5, and 2.0 years
研究概览
简要总结
This prospective study will enroll patients younger than 60 years with ischemic white matter lesions (WMIL) and age-matched healthy controls. We will measure circulating endothelial-related biomarkers, including endothelial progenitor cells (EPCs), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), asymmetric dimethylarginine (ADMA), and homocysteine (Hcy). We will also assess transcription levels of ICAM-1, VCAM-1, and ADMA. All participants will be followed and managed for 2 years, with repeated assessments of endothelial biomarkers and their transcriptional levels, as well as clinical and imaging evaluations. The aims are to characterize changes in endothelial biomarkers in WMIL, to determine how these changes relate to clinical features and imaging progression, and to evaluate whether statins protect endothelial function-by modifying these biomarkers-and thereby help treat WMIL and slow its progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 45-60 years.
- •Provides written informed consent.
- •WMIL group: consecutive outpatients/inpatients from the Neurology Department of Suzhou Municipal Hospital, with WMIL confirmed by brain MRI. Diagnostic features: symmetric, diffusely distributed, ill-defined lesions in periventricular and subcortical white matter; iso- or hypointense on T1WI; hyperintense on T2WI and FLAIR.
- •Control group: healthy individuals aged 45-60 years with brain MRI showing no intracranial lesions.
排除标准
- •Acute intracerebral hemorrhage or acute infarction on brain MRI or CT.
- •Central nervous system diseases that severely affect cognition, such as Alzheimer's disease or frontotemporal dementia.
- •White matter lesions due to other causes (e.g., toxic, genetic, immune, infectious, neoplastic, radiation-related).
- •Severe hepatic, renal, or cardiac insufficiency.
- •Recent major surgery or severe trauma.
- •History of psychiatric disorders that would preclude completion of study scales.
- •Unable to provide written informed consent.
研究组 & 干预措施
WMH - Intervention
Participants with WMH receiving oral atorvastatin 10 mg once daily at 18:00 (6 p.m.) for 24 months. Standard assessments will be performed at baseline and follow-up.
干预措施: Atorvastatin 10 mg daily (Drug)
WMH - Placebo
Participants with WMH receiving a placebo tablet matching atorvastatin, administered orally once daily at 18:00 (6 p.m.) for the same duration as the intervention arm. The same assessments will be performed.
干预措施: Placebo matching atorvastatin (Drug)
结局指标
主要结局
VACM1 levels at 0.5, 1.0, 1.5, and 2.0 years
时间窗: 0.5, 1, 1.5, and 2.0 years after baseline
次要结局
未报告次要终点