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

Recruiting

• Conditions: Cerebral Small Vessel Diseases; Health Behavior; Health Behavior, Risky; Dementia, Mixed
• Interventions: Other: Individuals with CSVD

• Registration Number: NCT06164262
• Lead Sponsor: Zhejiang Provincial People's Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-08
• Study First Posted: 2023-12-11
• Study Start: 2024-01-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Primary Completion: 2034-08-01
• Study Completion: 2034-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. 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.
2. Patients aged from 30 to 60 years.
3. Sign informed consent.

Exclusion Criteria

1. Unable to cooperate with inspectors.
2. Known dementia.
3. Other cognitive diseases (such as Alzheimer's disease, Parkinson's disease, or thyroid disease).
4. Serious systemic illness, such as heart, liver, kidney disease or major mental illness.
5. Contraindications for imaging examination.

Exit Criteria:

1. Not meet the inclusion criteria.
2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
3. Any adverse or serious adverse events during the study period judged by investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with CSVD	Individuals with CSVD	This does not entail the application of interventions.

Primary Outcome Measures

Name	Time	Method
Mini-mental State Examination (MMSE) score	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.

Secondary Outcome Measures

Name	Time	Method
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.	Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.
Blood flow density	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.	Record blood flow density (%) of OCTA.
Vascular perfusion area	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.	Record vascular perfusion area (mm\^2) of OCTA.
Macular fovea retinal thickness	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.	Record macular fovea retinal thickness (μm) of OCTA.
Retinal nerve fiber layer thickness	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.	Record retinal nerve fiber layer thickness (μm) of OCTA.
Resting state functional connectivity changes	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.	The study uses Resting state functional MRI (Rs-fMRI) to measure changes of functional connectivity across regions.
White matter Integrity	Baseline ,6-month, and every 1 year, follow-up time up to 10 years.	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.
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.	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.

Trial Locations

Locations (1)

Zhejiang Provincial People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China