Cerebral Small Vessel DiseasesDZM-CSVD-RNCT07342075
Registry Study of Cerebral Small Vessel Disease
An observational study of Cerebral Small Vessel Diseases and Cognitive Impairment, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Cerebral Small Vessel Diseases, Cognitive Impairment, Diffusion Tensor Imaging
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 Nov 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population mainly consisted of patients from the outpatient and inpatient departments of the Department of Neurology at Dongzhimen Hospital.
Who may be able to join
- 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.
Who cannot join
- 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.
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, 1 recruiting
- Recruiting
Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700
Beijing, Beijing Municipality
Beida Ren, PhD, +86-18810900836, 18810900836@163.com
Yupeng Wei, +86-15313972930, ccwyp2010@163.com
About this study
Official title: 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.
- Medical subject headings
- Cerebral Small Vessel Diseases, Cognitive Dysfunction
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 |
|---|---|---|
| Patient Gourp | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start13 Nov 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Dec 2026 (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 DiseasesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342075
- Sponsor's protocol ID
- 2025DZMEC-516-02
- Acronym
- DZM-CSVD-R
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Patient Registry Study of Cerebral Small Vessel Disease
- ClinicalTrials.gov ID
- NCT07342075
- Acronym / sponsor ID
- DZM-CSVD-R / 2025DZMEC-516-02
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Gourp | – | – |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population mainly consisted of patients from the outpatient and inpatient departments of the Department of Neurology at Dongzhimen Hospital.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in Montreal Cognitive Assessment (MoCA) at 6 month
Time frame: 6 months
Change from baseline in Montreal Cognitive Assessment (MoCA). Score range is 0-30. Higher score means good cognition.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Small Vessel Diseases and Cognitive Impairment, run by Dongzhimen Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beida Ren, PhD (+86-18810900836, 18810900836@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Montreal Cognitive Assessment (MoCA) at 6 month (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.