Registry for people with cerebral small vessel disease.

Real-world Patient Registry Study of Cerebral Small Vessel Disease

This project will collect clinical information and MRI scans from people aged 50 and older with MRI signs of cerebral small vessel disease to see how the condition relates to thinking, walking, and daily function over time.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Dongzhimen Hospital, Beijing (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07342075 on ClinicalTrials.gov

What this trial studies

This is an observational registry enrolling adults aged 50 and older with MRI-confirmed cerebral small vessel disease. Participants will undergo standardized MRI (including diffusion tensor imaging), clinical evaluations, and cognitive testing at baseline and at planned follow-up visits to track changes over time. Key exclusions include recent large stroke or intracranial hemorrhage, significant non-vascular white matter disease, and other known causes of cognitive impairment to keep the cohort specific to CSVD. Collected data aim to link imaging features with clinical and cognitive outcomes to inform future targeted interventions.

Who should consider this trial

Good fit: Adults aged 50 or older with MRI-confirmed typical imaging changes of cerebral small vessel disease who can provide informed consent and attend the Beijing study site.

Not a fit: People with recent acute ischemic stroke or intracranial hemorrhage, significant non-vascular white matter disease, other known causes of cognitive impairment, or severe organ failure are excluded and therefore unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the registry could improve diagnosis and prognosis of CSVD and help researchers design targeted treatments for CSVD-related cognitive decline.

How similar studies have performed: Previous observational registries and imaging studies have linked CSVD imaging markers to cognitive and motor outcomes, but registry data have not yet produced proven targeted therapies.

Eligibility criteria

Inclusion Criteria:

1. Age above 50 years (including 50-year-old);
2. MRI confirmed the presence of typical imaging changes of CSVD;
3. Voluntary participation in the study and be willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Patients with acute ischemic stroke or acute intracranial hemorrhage (e.g., epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intracerebral hemorrhage, etc.) or a history of cerebral infarction (non-lacunar) or intracranial hemorrhage within the past 3 months;
2. Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);
3. Patients with a history of cognitive impairment due to other causes (e.g., normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.);
4. Severe hepatic, renal, or cardiac insufficiency (ALT or AST \>2 times the upper limit of normal, or serum creatinine \>1.5 times the upper limit of normal, or New York Heart Association \[NYHA\] functional class III or IV);
5. Patients with psychiatric disorders that affect study medication administration and evaluation;
6. Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.);
7. Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons;
8. Participation in other clinical trial projects.

Where this trial is running

Beijing, Beijing Municipality

• Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700 — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Beida Ren, PhD

Conditions: Cerebral Small Vessel Diseases, Cognitive Impairment, Diffusion Tensor Imaging