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NCT Number: NCT07093515

Biomarkers, Risk Assessment, Imaging, and Neurodegeneration in Cerebral Small Vessel Disease (BRAIN-CSVD)

The BRAIN-CSVD study is a single-center prospective cohort study focusing on cerebral small vessel disease (CSVD).Patients enrolled in this research will undergo assessments for vascular risk factors, cognitive and other neurological functions, neuroimaging, and biomarkers. The study aims to explore imaging and biomarker predictors of CSVD progression, and the pathophysiological mechanisms of CSVD.

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Key information

About this study

Cerebral small vessel disease (CSVD) is a common imaging finding in elderly population and can impair cognitive and other neurological functions. Radiologically, CSVD may manifest as white matter hyperintensities, lacunes, cerebral microbleeds, enlarged perivascular spaces and so on. Due to its complex imaging presentations and diverse neurological impacts, current preventive and therapeutic options for CSVD remain limited. This study involves collecting vascular risk factors, assessing global cognitive function, gait, and other neurological functions, performing multimodal MRI scans, and collecting blood samples from CSVD patients. The goal is to identify imaging markers and biomarkers that predict disease progression and to investigate the underlying pathophysiological mechanisms.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age >= 18 years old;
  • Cerebral small vessel disease on MR imaging.

Exclusion criteria

  • Cerebral infarction (except lacunar infarcts), cerebral hemorrhage, brain tumors, epilepsy, severe traumatic brain injury, or prior brain surgery;
  • Secondary white matter hyperintensities due to inflammatory, toxic causes and so on;
  • Contraindications to MRI.

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. Cognitive function

    Time frame: Follow-up assessments will be conducted at the 2nd year and 4th year

    Montreal Cognitive Assessment (MoCA) score, with a range of 0 to 30 points, where higher scores indicate better cognitive function.

Secondary outcomes

  1. Stroke

    Time frame: Follow-up assessments will be conducted at the 2nd year and 4th year

    The rate of the patients with ischemic stroke or cerebral hemorrhagic stroke

Study contacts

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

Junjun Wang

CONTACT

[email protected]

8613777848063

Sponsors and collaborators

Lead sponsor

Zhejiang Hospital

Other

Registry information

Official study title

A Cohort Study of Biomarkers, Risk Assessment, Imaging, and Neurodegeneration in Patients With Cerebral Small Vessel Disease

Acronym: BRAIN-CSVD

Important dates

Study start
2025
Primary completion
2030
Study completion
2032
First posted
Jul 30, 2025
Registry last updated
Jul 30, 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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