The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital

NCT07726654 | Not Yet Recruiting DMC

• 1 other identifier: RJNeuroBank-SVD
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Small Vessel Disease

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Brain volume

  baseline, 1 year, 2-year, 3-year, 5-year,10-year

• Connectivity integrity of the neural circuit

  baseline, 1 year, 2-year, 3-year, 5-year,10-year

• Volume of white matter lesions

  baseline, 1 year, 2-year, 3-year, 5-year,10-year

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age ≥18 years.
• 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.
• Independent in activities of daily living (modified Rankin Scale \[mRS\] ≤2).
• Able and willing to provide written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, and DNA extracted from white blood cell

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 24, 2026
• Study Start: July 8, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 24, 2026

Record last verified: 2026-06

Locations

CN (1)