Registry Study of Cerebral Small Vessel Disease (DZM-CSVD-R)

Real-world Patient Registry Study of Cerebral Small Vessel Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Impairment; Cerebral Small Vessel Diseases; Diffusion Tensor Imaging

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Beida Ren, PhD; Phone Number: +86-18810900836; Email: 18810900836@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700
      • Contact: Yupeng Wei; Phone Number: +86-15313972930; Email: ccwyp2010@163.com
      • Contact: Beida Ren, PhD; Phone Number: +86-18810900836; Email: 18810900836@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patient Gourp

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Mini-Mental State Examination (MMSE) at 6 month	Change from baseline in Mini-Mental State Examination (MMSE). Score range is 0-30. Higher score means good cognition.	6 months
Changes in whole-brain fiber connectivity at 6 month	Measure changes in whole-brain fiber connectivity on brain MRI diffusion tensor imaging (DTI).	6 months
Change from baseline in trail making test (TMT) at 6 month	Change from baseline in trail making test (TMT).TMT contains TMT-A and TMT-B. Both are related to age and education. The longer the duration of both tests, the poorer the ability to concentrate, process and perform.	6 months
Change from baseline in Tinetti Performance Oriented Mobility Assessment (POMA) at 6 month	Change from baseline in Tinetti Performance Oriented Mobility Assessment (POMA). Score range is 0-28. Lower score means higher risk of falling.	6 months
Change from baseline in instrumental activities of daily living (IADL) at 6 month	Change from baseline in instrumental activities of daily living (IADL). Score range is 0-24. Higher score means better daily living.	6 months
Change from baseline in Modified Rankin Scale (mRS) at 6 month	Change from baseline in Modified Rankin Scale (mRS).Score range is 0-6. Higher score means greater disability.	6 months
Change from baseline in the symptom at 6 month	Change from baseline in the symptom. The study plans to analyze whether there are statistically significant differences in the incidence of major symptoms before and after treatment. Patient-reported outcomes (PROs) will be used to record the degree of change in patients' symptoms from baseline (expressed as a percentage, with >100% indicating symptom worsening and <100% indicating symptom relief). Meanwhile, baseline and 6-month tongue coating photos will be preserved.	6 months
Change from baseline in gut microbiota at 6 month	Change from baseline in gut microbiota. Metagenomic sequencing technology will be applied to the analysis.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers in new vascular events from baseline to 6 month	New vascular events include ischemic stroke, TIA, cerebral hemorrhage, MI, pulmonary embolism, thrombosis, peripheral arterial occlusion	6 months
Numbers in all-cause hospitalization from baseline to 6 month	Numbers in all-cause hospitalization	6 months

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Cerebral Small Vessel Diseases
• Other Study ID Numbers: 2025DZMEC-516-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No