Dementia Risk Registry for Young and Middle-aged CSVD Patients in the Next 10 Years

Study Overview
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Brief Summary
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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.

Official Title
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Dementia Risk rEgistry for Young And Middle-aged CSVD Patients in the Next 10 Years（DREAM-10）

Conditions
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Cerebral Small Vessel Diseases, Dementia, Mixed, Health Behavior, Health Behavior, Risky

Intervention / Treatment
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* Other: Individuals with CSVD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals with CSVD<br>This does not entail the application of interventions. | Other: Individuals with CSVD<br>* This does not entail the application of interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini-mental State Examination (MMSE) score | 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. | Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The development of total brain small vessel disease burden in MRI | Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points. | Baseline ,6-month, and every 1 year, follow-up time up to 10 years. | 
| Blood flow density | Record blood flow density (%) of OCTA. | Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | 
| Vascular perfusion area | Record vascular perfusion area (mm^2) of OCTA. | Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | 
| Macular fovea retinal thickness | Record macular fovea retinal thickness (μm) of OCTA. | Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | 
| Retinal nerve fiber layer thickness | Record retinal nerve fiber layer thickness (μm) of OCTA. | Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | 
| Resting state functional connectivity changes | The study uses Resting state functional MRI (Rs-fMRI) to measure changes of functional connectivity across regions. | Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | 
| White matter Integrity | The study uses Diffusion Tensor Imaging (DTI) to obtain FA and MD values, which are used to measure changes in the integrity of white matter. | Baseline ,6-month, and every 1 year, follow-up time up to 10 years. | 
| Number of Patients with cerebrovascular events, cardiovascular events, or death | Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA) and cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death. | Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dementia, Cerebral Small Vessel Diseases, Cardiovascular health