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Not yet recruitingNCT07726654Updated Jul 24, 2026

The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

An observational study in Cerebral Small Vessel Disease, sponsored by Ruijin Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Ruijin Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this observational study is to learn about neuroimage and biomarkers in the cerebral small vessel disease. The main questions it aims to answer are:

  • How does neurovascular coupling change during the progression of CSVD?
  • How is the pattern/mapping of alterations in CSVD biomarkers? Participants will be observed and visit the research center annually to perform multi-modal MRI, PET, neuropsychological tests, and blood tests.
Read the detailed description

This observational study recruits participants with cerebral small vessel disease (CSVD) from hospitals and community-based populations. Healthy volunteers will also be recruited as controls. Longitudinal follow-up of these participants will help clarify the significance of neuroimaging and biological biomarkers during the development and progression of CSVD.

The investigators aim to establish a longitudinal cohort covering the spectrum of CSVD and identify key biomarkers associated with disease progression and cognitive decline. All participants will undergo multimodal MRI, PET imaging (optional) with different tracers, and blood biomarker assessments. Using multimodal MRI, the investigators will investigate alterations in neurovascular coupling and their role in the pathophysiology of CSVD. In addition, PET imaging (optional) and blood biomarkers will be used to characterize the spatial and temporal patterns of disease-related biomarker changes. Furthermore, additional neuroimaging and digital biomarkers will be evaluated within the cohort to improve disease characterization and prognostic prediction.

02

Conditions studied

  • Cerebral Small Vessel Disease
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The population consists of vascular dementia, vascular mild cognitive impairment, and cognitively normal participants.

Inclusion criteria

  1. Age ≥18 years.

  2. Evidence of cerebral small vessel disease (CSVD) on brain MRI, meeting at least one of the following imaging criteria:

    • White matter hyperintensities (WMH) with a total Fazekas score ≥2;
    • Fazekas score =1 with at least two vascular risk factors (hypertension, hyperlipidemia, diabetes mellitus, obesity, current smoking, or a history of vascular events other than stroke);
    • Fazekas score =1 accompanied by the presence of lacunes;
    • Imaging evidence of a recent subcortical lacunar infarction.
  3. Independent in activities of daily living (modified Rankin Scale [mRS] ≤2).
  4. Able and willing to provide written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Acute ischemic stroke with a diffusion-weighted imaging (DWI) lesion >20 mm in diameter.
  2. Acute intracerebral hemorrhage.
  3. Acute subarachnoid hemorrhage, a history of aneurysmal subarachnoid hemorrhage or cerebrovascular malformation, or the presence of an untreated intracranial aneurysm >3 mm in diameter.
  4. Previously diagnosed neurodegenerative disorders, such as Alzheimer's disease (AD) or Parkinson's disease (PD).
  5. Definite non-vascular white matter diseases, including multiple sclerosis, adult-onset leukodystrophy, metabolic encephalopathy, or other non-vascular white matter disorders.
  6. Major psychiatric disorders diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
  7. Contraindications to MRI (e.g., severe claustrophobia or MRI-incompatible implants).
  8. Severe systemic diseases (e.g., active malignancy) with an expected life expectancy of less than 5 years.
  9. Inability to complete scheduled follow-up because of geographic, logistical, or other reasons.
  10. Concurrent participation in another interventional clinical trial.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Cognitively Normal

    Participants do not have cognitive impairment.

  • Cerebral small vessel disease without dementia

    Participants have vascular cognitive impairment, but no cognitive impairment

  • Vascular Dementia (VaD)

    Participants have vascular cognitive impairment or difficulty in daily activity.

05

What researchers measure

Primary outcomes

  1. Global cognitive ability

    Mini-mental state examination

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  2. Executive function

    Clock drawing test

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  3. Visual memory

    Rey-Osterich complex figure test

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  4. Short-term memory

    Auditory verbal learning test

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  5. Executive memory

    Symbol-digit test

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  6. Spatial executive function

    Trail making test

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  7. Naming ability

    Boston naming test

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  8. Language ability

    Language fluency test

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  9. Sleep quality

    Sleep disorder

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  10. Movement ability

    Part III of the Unified Parkinson's Disease Rating Scale

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

Secondary outcomes

  1. Brain volume

    Annual changes of volumes of brain

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  2. Connectivity integrity of the neural circuit

    Annual changes of hippocampus related neural connectivity

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

  3. Volume of white matter lesions

    Structural and functional MRI measures, including arterial spin labeling (ASL), diffusion MRI (dMRI), susceptibility-weighted imaging (SWI) and fluid-attenuated inversion recovery (FLAIR).

    Time frame: baseline, 1 year, 2-year, 3-year, 5-year,10-year

06

Study locations

1 site
  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai Municipality 200025, China
    • Jingyan Tian, Dr · Contact · tjy11488@rjh.com.cn · 13671865057
    • Jingwen Jiang, Dr. · Principal investigator
    • Binyin Li, Dr. · Sub investigator
07

References and documents

Individual participant data

Plan to share: Undecided — There is not yet a plan to make IPD available to other researchers

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07726654
Lead sponsor
Ruijin Hospital
Responsible party
Sponsor
First posted
Jul 24, 2026
Start date
Jul 8, 2026 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Jul 24, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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