An observational study in Cerebral Small Vessel Diseases, Dementia, Mixed and Health Behavior, sponsored by Zhejiang Provincial People's Hospital. Recruiting at 1 site in China. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Zhejiang Provincial People's Hospital · Observational
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.
128 studies on the registry are indexed under Cerebral Small Vessel Diseases; 71 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 260 across 56 observational studies indexed under Cerebral Small Vessel Diseases.
Browse Cerebral Small Vessel Diseases studies →Zhejiang Provincial People's Hospital is the lead sponsor of 62 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The research population for this study consists of patients who have been diagnosed with Cerebral Small Vessel Disease. The inclusion criteria are: 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. The exclusion criteria are: Unable to cooperate with inspectors; Known dementia; Serious systemic illness, such as heart, liver, kidney disease or major mental illness; Contraindications for imaging examination. The exit criteria are: 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. The patients will be recruited from Zhejiang Provincial People's Hospital in the city of Hangzhou.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Exit Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This does not entail the application of interventions.
Other: Individuals with CSVD
This does not entail the application of interventions.
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.
Time frame: 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
Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.
Time frame: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
Blood flow density
Record blood flow density (%) of OCTA.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Plan to share: No
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Cerebral Small Vessel Diseases →
Zhejiang Provincial People's Hospital