Registry for young and middle-aged patients with cerebral small vessel diseases and dementia risk
Dementia Risk rEgistry for Young And Middle-aged CSVD Patients in the Next 10 Years（DREAM-10）
This study is trying to see how small blood vessel problems in the brain affect thinking skills in younger adults aged 30 to 60 who don’t have dementia yet.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | Zhejiang Provincial People's Hospital Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06164262 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between cerebral small vessel diseases (CSVD) and cognitive impairment in individuals aged 30 to 60 years who show imaging markers of CSVD but do not have known dementia. Participants will undergo neuropsychological assessments and multimodal MRI scans, along with Optical Coherence Tomography Angiography (OCTA) to evaluate retinal health. The study will collect clinical data and follow participants over time to better understand the progression of cognitive decline in this demographic. By focusing on younger patients, the study seeks to fill a gap in knowledge regarding CSVD's impact on cognitive health.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 60 years with MRI markers indicative of cerebral small vessel diseases and no known dementia.
Not a fit: Patients with known dementia or other cognitive diseases, as well as those with serious systemic illnesses, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to early identification and intervention strategies for dementia in younger individuals with CSVD.
How similar studies have performed: While studies on CSVD and dementia in older populations have shown significant findings, this specific focus on younger patients is relatively novel and less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Sheng Zhang, M.D.
- Email: zhangsheng@hmc.edu.cn
- Phone: +8618758188313
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.