Dementia Risk rEgistry for Young And Middle-aged CSVD Patients in the Next 10 Years（DREAM-10）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Mini-mental State Examination (MMSE) score
研究概览
简要总结
Age-related cerebral small-vessel disease (CSVD) is a major cause of dementia, predominantly affecting individuals over 60 years of age, with a prevalence exceeding 70% in the elderly population. However, the correlation between the burden of CSVD and the progression of cognitive impairment in young and middle-aged individuals remains uncertain. DREAM-10 is an observational, prospective study that enrolled individuals aged 30-60 years, who were free from known dementia but exhibited imaging markers related to CSVD. Through prospective registration and follow-up, this study will collect data on patients with CSVD, including clinical information, neuropsychological assessments, multimodal Magnetic Resonance Images (MRI) and retinopathy characterized by Optical Coherence Tomography Angiography (OCTA). CSVD related features seen on neuroimaging include recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, brain atrophy, cortical superficial siderosis. Utilizing this data, the researchers aim to investigate the potential dementia risk among young and middle-aged individuals with CSVD over the forthcoming decade, along with identifying its predictive factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with any of the CSVD-related MRI imaging markers, including recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and superficial cortical siderosis.
- •Patients aged from 30 to 60 years.
- •Sign informed consent.
排除标准
- •Unable to cooperate with inspectors.
- •Known dementia.
- •Other cognitive diseases (such as Alzheimer's disease, Parkinson's disease, or thyroid disease).
- •Serious systemic illness, such as heart, liver, kidney disease or major mental illness.
- •Contraindications for imaging examination.
- •Exit Criteria:
- •Not meet the inclusion criteria.
- •For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
- •Any adverse or serious adverse events during the study period judged by investigator.
结局指标
主要结局
Mini-mental State Examination (MMSE) score
时间窗: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
To assess changes in cognitive function of patients. Adopt education level adjustment value (illiteracy, primary school, middle school, university respectively adopt ≤22points, ≤23 points, ≤24 points, ≤26 points) to define dementia.
次要结局
- Blood flow density(Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.)
- The development of total brain small vessel disease burden in MRI(Baseline ,6-month, and every 1 year, follow-up time up to 10 years.)
- Vascular perfusion area(Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.)
- Macular fovea retinal thickness(Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.)
- Retinal nerve fiber layer thickness(Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.)
- Resting state functional connectivity changes(Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.)
- White matter Integrity(Baseline ,6-month, and every 1 year, follow-up time up to 10 years.)
- Number of Patients with cerebrovascular events, cardiovascular events, or death(Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.)