Registry Study of Cerebral Small Vessel Disease

NCT07342075 | Recruiting

• 1 other identifier: 2025DZMEC-516-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The incidence of cerebral small vessel disease (CSVD) increases with age, affecting approximately 5% of individuals over 50 years old and nearly all individuals over 90 years old. CSVD is also the most important vascular factor contributing to cognitive decline, with 45% of dementia patients attributed to CSVD. Existing interventions are similar to secondary prevention strategies for cardiovascular and cerebrovascular diseases, and no specific therapies are currently available. CSVD-related cognitive impairment (CSVDCI) predominantly involves attention, processing speed, and executive functions, with relatively preserved memory function, and may be accompanied by non-cognitive clinical manifestations such as gait disturbances, emotional and behavioral disorders, and bladder dysfunction. Although CSVDCI can be classified under vascular cognitive impairment (VCI), there are certain differences in its clinical manifestations. In summary, it is necessary to develop more targeted treatments for CSVD. We attempt to establish a "symptom-tongue coating-gut microbiota-imaging" system to provide data support for the subsequent exploration of CSVD treatments based on traditional Chinese medicine (TCM) syndrome differentiation and treatment.

Conditions

Diffusion Tensor Imaging; Cerebral Small Vessel Diseases; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Montreal Cognitive Assessment (MoCA) at 6 month

  Change from baseline in Montreal Cognitive Assessment (MoCA). Score range is 0-30. Higher score means good cognition.

  6 months

Secondary Outcomes (8)

• Change from baseline in Mini-Mental State Examination (MMSE) at 6 month

  6 months

• Changes in whole-brain fiber connectivity at 6 month

  6 months

• Change from baseline in trail making test (TMT) at 6 month

  6 months

• Change from baseline in Tinetti Performance Oriented Mobility Assessment (POMA) at 6 month

  6 months

• Change from baseline in instrumental activities of daily living (IADL) at 6 month

  6 months

Other Outcomes (2)

• Numbers in new vascular events from baseline to 6 month

  6 months

• Numbers in all-cause hospitalization from baseline to 6 month

  6 months

Study Arms (1)

Patient Gourp

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population mainly consisted of patients from the outpatient and inpatient departments of the Department of Neurology at Dongzhimen Hospital.

You may qualify if:

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

You may not qualify if:

• 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;
• Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);
• 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.);
• 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);
• Patients with psychiatric disorders that affect study medication administration and evaluation;
• Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.);
• Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons;
• Participation in other clinical trial projects.

Sponsors & Collaborators

• Dongzhimen Hospital, Beijing: lead

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700

Beijing, Beijing Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool specimens from patients will be collected.

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Beida Ren, PhD

CONTACT

+86-18810900836; 18810900836@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: November 13, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

CN (1)