The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Small Vessel Disease

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200025
      • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
      • Contact: Jingyan Tian, Dr; Phone Number: 13671865057; Email: tjy11488@rjh.com.cn
      • Principal Investigator: Jingwen Jiang, Dr.
      • Sub-Investigator: Binyin Li, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cognitive ability	Mini-mental state examination	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive function	Clock drawing test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Visual memory	Rey-Osterich complex figure test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Short-term memory	Auditory verbal learning test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive memory	Symbol-digit test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Spatial executive function	Trail making test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Naming ability	Boston naming test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Language ability	Language fluency test	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Sleep quality	Sleep disorder	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Movement ability	Part III of the Unified Parkinson's Disease Rating Scale	baseline, 1 year, 2-year, 3-year, 5-year,10-year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain volume	Annual changes of volumes of brain	baseline, 1 year, 2-year, 3-year, 5-year,10-year
Connectivity integrity of the neural circuit	Annual changes of hippocampus related neural connectivity	baseline, 1 year, 2-year, 3-year, 5-year,10-year
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).	baseline, 1 year, 2-year, 3-year, 5-year,10-year

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 8, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cerebral Small Vessel Diseases
• Other Study ID Numbers: RJNeuroBank-SVD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is not yet a plan to make IPD available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No