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

Zhejiang Provincial People's Hospital

Status: Enrolling

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

Treatments: Other: Individuals with CSVD

Study type: Observational

Funder types: Other

Identifiers

NCT06164262

KY2023054

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,000 participants in 1 patient group

Individuals with CSVD

Description:

This does not entail the application of interventions.

Treatment:

Other: Individuals with CSVD