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Recruiting Observational

Dementia Risk Registry Across the Multidimensional Lifespan: A 10-Year Study

NCT06164262 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-01-01
Last updated
2026-09-17

Condition(s) studied

Cerebral Small Vessel DiseasesDementia, MixedHealth BehaviorHealth Behavior, Risky

Investigational drug(s) / intervention(s)

Individuals with CSVD

Individuals with CSVD: This does not entail the application of interventions.

Study 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.

Eligibility

Sex
ALL
Min age
30 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Zhejiang Provincial People's Hospital Hangzhou Zhejiang Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06164262 on ClinicalTrials.gov ↗ ← All trials in China