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Recruiting NCT07342075

Registry Study of Cerebral Small Vessel Disease

— Observational Cerebral Small Vessel Diseases Cognitive Impairment Diffusion Tensor Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cerebral Small Vessel Diseases, Cognitive Impairment, Diffusion Tensor Imaging. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real-world Patient Registry Study of Cerebral Small Vessel Disease

Overview

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.

Primary outcome measures

  • Change from baseline in Montreal Cognitive Assessment (MoCA) at 6 month [Time frame: 6 months]
Secondary outcome measures (8)
  • Change from baseline in Mini-Mental State Examination (MMSE) at 6 month [Time frame: 6 months]
  • Changes in whole-brain fiber connectivity at 6 month [Time frame: 6 months]
  • Change from baseline in trail making test (TMT) at 6 month [Time frame: 6 months]
  • Change from baseline in Tinetti Performance Oriented Mobility Assessment (POMA) at 6 month [Time frame: 6 months]
  • Change from baseline in instrumental activities of daily living (IADL) at 6 month [Time frame: 6 months]
  • Change from baseline in Modified Rankin Scale (mRS) at 6 month [Time frame: 6 months]
  • Change from baseline in the symptom at 6 month [Time frame: 6 months]
  • Change from baseline in gut microbiota at 6 month [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700 — Beijing

Identifiers

NCT: NCT07342075 · 2025DZMEC-516-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗