ClinicalTrials.gg
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

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

Where this study stands

Counted across the records on this site · 2026-11-13

Among 48 studies in Cerebral Small Vessel Diseases with a site in China — 32 open to participants now, 33 under way, 1 of them phase 3. Cerebral Small Vessel Diseases · China.

Planned enrollment
13th of 22
400 · median 749
Started
2026
with 4 others
Observational
22 of 48
19 open now
Primary completion
2028-09
later than 21 of 32 live
Registered
47th of 48
by date

Among the 48 studies in Cerebral Small Vessel Diseases with a site in China, this one is the 13th largest by planned enrollment of the 22 observational ones that give a count, is one of 5 that started in 2026, is one of 22 observational ones, reaches primary completion later than 21 of the 32 other live ones, and was the 47th registered.

Cerebral Small Vessel Diseases

128 studies on the registry are indexed under Cerebral Small Vessel Diseases; 71 are open to participants now.

Browse Cerebral Small Vessel Diseases studies →

Open to participants now

32 of the 48 studies in Cerebral Small Vessel Diseases with a site in China are open now. Recruiting first, the newest first:

27 more — sign in →

All 32 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 46 Cerebral Small Vessel Diseases studies recruiting now, 26 (57%) set no upper age limit and 5 (11%) stop at 75 or younger; 2 take children under 18; 11 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

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.

03

Conditions studied

  • Cerebral Small Vessel Disease
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

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 , Fifth Edition (DSM-5).
  7. to MRI (e.g., severe claustrophobia or MRI-incompatible implants).
  8. Severe systemic diseases (e.g., active ) with an expected 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

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.

06

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

07

Study locations

1 site
  • Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai Municipality 200025, China
    • Jingyan Tian, Dr · Contacttjy11488@rjh.com.cn · 13671865057
    • Jingwen Jiang, Dr. · Principal investigator
    • Binyin Li, Dr. · Sub investigator
08

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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2026; primary completion for Sep 2028, 26 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 10, 2026
First posted
Jul 24, 2026
StartEst.
Jul 8, 2026
Primary completionEst.
Sep 30, 2028
CompletionEst.
Dec 31, 2028
Last update
Jul 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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