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NCT Number: NCT06164262

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

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.

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Key information

Conditions

Cerebral Small Vessel Diseases Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Dementia, Mixed Health Behavior Health Behavior, Risky Health Risk Behaviors Mental Disorders Mixed Dementias Nervous System Diseases Neurocognitive Disorders Vascular Diseases

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Sheng Zhang, M.D.

CONTACT

[email protected]

+8618758188313

Sheng Zhang, M.D.

PRINCIPAL_INVESTIGATOR

Weitao Yu, B.S.Med

SUB_INVESTIGATOR

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Exit Criteria:

  • 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.

Treatment and study plan

Individuals with CSVD

Other

This does not entail the application of interventions.

Primary outcomes

  1. Mini-mental State Examination (MMSE) score

    Time frame: 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 outcomes

  1. The development of total brain small vessel disease burden in MRI

    Time frame: 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.

  2. Blood flow density

    Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

    Record blood flow density (%) of OCTA.

  3. Vascular perfusion area

    Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

    Record vascular perfusion area (mm^2) of OCTA.

  4. Macular fovea retinal thickness

    Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

    Record macular fovea retinal thickness (μm) of OCTA.

  5. Retinal nerve fiber layer thickness

    Time frame: 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.

  6. Resting state functional connectivity changes

    Time frame: 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.

  7. White matter Integrity

    Time frame: 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.

  8. Number of Patients with cerebrovascular events, cardiovascular events, or death

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Zhang, M.D.

CONTACT

[email protected]

+8618758188313

Sponsors and collaborators

Lead sponsor

Zhejiang Provincial People's Hospital

Other

Registry information

Official study title

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

Acronym: DREAM-10

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Dec 11, 2023
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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