Cerebral Small Vessel DiseaseNCT07726654
The Longitudinal Cohort of Cerebral Small Vessel Disease in Ruijin Hospital
An observational study of Cerebral Small Vessel Disease, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cerebral Small Vessel Disease
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2026to 31 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population consists of vascular dementia, vascular mild cognitive impairment, and cognitively normal participants.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jingyan Tian, Dr, 13671865057, tjy11488@rjh.com.cn
Jingwen Jiang, Dr.
About this study
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.
- Conditions
- Cerebral Small Vessel Disease
- Medical subject headings
- Cerebral Small Vessel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive ability
Mini-mental state examination
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive function
Clock drawing test
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Visual memory
Rey-Osterich complex figure test
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Short-term memory
Auditory verbal learning test
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Executive memory
Symbol-digit test
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Spatial executive function
Trail making test
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Naming ability
Boston naming test
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Language ability
Language fluency test
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Sleep quality
Sleep disorder
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Movement ability
Part III of the Unified Parkinson's Disease Rating Scale
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Secondary outcomes (3)
Brain volume
Annual changes of volumes of brain
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Connectivity integrity of the neural circuit
Annual changes of hippocampus related neural connectivity
Measured: 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).
Measured: baseline, 1 year, 2-year, 3-year, 5-year,10-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start8 Jul 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Small Vessel DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726654
- Sponsor's protocol ID
- RJNeuroBank-SVD
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: There is not yet a plan to make IPD available to other researchers