A Phase 2 interventional study of GLP-1 receptor agonist in Cerebral Small Vessel Disease, sponsored by Chinese University of Hong Kong. Recruiting at 2 sites in 2 countries. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Chinese University of Hong Kong · Phase 2, Interventional, and Treatment
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Among 48 studies in Cerebral Small Vessel Diseases with a site in China — 32 open to participants now, 33 under way, 1 of them phase 3. Cerebral Small Vessel Diseases · China.
Among the 48 studies in Cerebral Small Vessel Diseases with a site in China, this one is the 13th largest by planned enrollment of the 26 interventional ones that give a count, is one of 8 that started in 2022, is one of 3 in phase 2, reaches primary completion later than 13 of the 32 other live ones, and was the 16th registered.
128 studies on the registry are indexed under Cerebral Small Vessel Diseases; 71 are open to participants now.
Browse Cerebral Small Vessel Diseases studies →32 of the 48 studies in Cerebral Small Vessel Diseases with a site in China are open now. Recruiting first, the newest first:
Dongzhimen Hospital, Beijing · Sites in China
Ages 50+
Peking Union Medical College Hospital · Sites in China
Ages 30–80
Beijing Tiantan Hospital · Sites in China
Ages 45–80
The First Affiliated Hospital with Nanjing Medical University · Sites in China
Ages 30–79
Beijing Tiantan Hospital · Sites in China
Ages 50–75 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 46 Cerebral Small Vessel Diseases studies recruiting now, 26 (57%) set no upper age limit and 5 (11%) stop at 75 or younger; 2 take children under 18; 11 take healthy volunteers.
This study: 55 Years to 80 Years · all sexes · no healthy volunteers.
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48 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 8 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 110 is above the median of 86 across 72 interventional studies indexed under Cerebral Small Vessel Diseases.
Median enrollment 105 across the 26 interventional studies, 749 across the 22 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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None of the 48 has an industry lead sponsor. The 10 most frequent:
Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Chinese University of Hong Kong has 4 studies filed under Cerebral Small Vessel Diseases — fewer than ten, so there is no comparison to draw.
8 of the studies in Cerebral Small Vessel Diseases with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06674460Phase 3Peking Union Medical College HospitalTreatment of Acute Ischemic Stroke With Edaravone Dexborneol Sublingual Tablets in Small Vessel Disease | 2027-10-01 |
| NCT07317557Jiangsu Province Nanjing Brain HospitalRemote Ischemic Conditioning for Cognitive Impairment in Cerebral Small Vessel Disease | 2026-12-31 |
| NCT07271732Dongzhimen Hospital, BeijingSongling Xuemaikang Capsules for Cerebral Small Vessel Disease | 2026-12-31 |
| NCT05356104Chinese University of Hong KongGLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD) | 2027-05 |
| NCT06512376Beijing Tiantan HospitalHereditary Cerebral Small Vessel Diseases Registry-Trial Ready Cohort | 2027-07-19 |
Add all 8 to your calendar (.ics) → With an account.
Among the 48 studies in Cerebral Small Vessel Diseases with a site in China, from their registry updates:
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Cerebral small vessel disease (cSVD), a result of neurovascular cell dysfunction, is a major cause of stroke, dementia and mobility problems worldwide. Vascular risk factor control alone may not be sufficient to prevent the development of vascular cognitive impairment (VCI) in patients with cSVD according to previous clinical trials.
The presence of glucagon-like peptide-1 receptor (GLP-1R) in cerebral microglia may reveal a potential therapeutic target for prevention of cSVD progression and its disabling clinical outcomes. At the cellular and animal experimentation levels, GLP-1R agonist demonstrated reversal of some pathogenic processes in cSVD. However, its application to cSVD patients remains to be elucidated.
Investigator aims to investigate the safety and efficacy of GLP-1R agonist in patients with moderate-to-severe cSVD.
In this single-center, open-label (assessor blinded), randomized controlled study, 110 patients with cSVD of Age-Related White Matter Changes Scale of 2 or 3 will be randomized into "treatment arm" with GLP-1R agonist and standard medical therapy, and "control" arm with standard medical therapy alone in a 1:1 ratio. In this 78 weeks pilot study, investigators shall evaluate the tolerability and safety profile of GLP-1R agonist in SVD patients, together with changes in clinical, imaging and sonographic parameters.
Clinical and biochemical measures will be assessed at baseline, 12 weeks, 26 weeks and 52 weeks. Transcranial Doppler Ultrasound (TCD) will be performed at baseline, 12 weeks, 26 weeks, 52 weeks and 78 weeks. MRI will be performed at baseline and 78 weeks
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prescribe study drug: GLP-1 receptor agonist. The dosage and frequency is 2mg once weekly via subcutaneous injection for 78 weeks for Bydureon bcise (exenatide), the dosage and frequency is 0.25mg once weekly for 4 weeks followed by 0.5mg once weekly for 74 weeks via subcutaneous injection for Ozempic (semaglutide)
Drug: GLP-1 receptor agonist
Standard medical therapy
2mg once weekly via subcutaneous injection
Also known as: Bydureon BCise, Ozempic
This study also gives Semaglutide. No intervention listed here names it: that was found by reading the record.
Change of Brain Peak Width of Skeletonized Mean Diffusivity
Peak Width of Skeletonized Mean Diffusivity is a robust, fully-automated and easy-to-implement marker for cerebral small vessel disease based on diffusion tensor imaging, white matter tract skeletonization and histogram analysis. It is a biomarker for brain MRI images.
Time frame: Baseline and week 78
Number of recurrent stroke
Record of any recurrent stroke from medical note/system
Time frame: Baseline and week 78
Change of Hong Kong MOntreal Cognitive Assessment
Hong Kong MOntreal Cognitive Assessment (HK-MoCA) is a cognitive assessment tool. Score from 0 to 30 . The lower score reflect the worse the outcome.
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change The Chinese Geriatric Depression Scale 30
The Chinese Geriatric Depression Scale is used to detect depressive mood. Score 0 to 30. The higher the score, the worse the outcome
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of Pittsburgh sleep quality index
Pittsburgh sleep quality index Chinese Version is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The questionnaire contains frequency questions related to sleep quality, each question scale from 0 to 3. The higher the score, the worse the outcome. There is no total score available for this assessment
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of Hong Kong List Learning Test
Hong Kong List Learning Test s a newly developed Chinese memory test designed for the assessment of the processes and organizational strategies involved in learning verbal information. The more negative the standard deviation the worse the outcome
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of Neuropsychiatric Inventory
Neuropsychiatric Inventory is a brief interview with a family member or friend who knows the study subject . It is used to measure behavioral symptoms. It evaluates 12 behavioral areas commonly affected in patients with dementia. It evaluates the frequency (scale from 1 to 4), severity (scale from 1 to 3), distress to caretaker (scale from 1 to 5) of each behavioral symptom. The higher the score of any area means the worse outcome. There is no total score available for this assessment
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of disability assessment for dementia
Disability assessment for dementia evaluates 11 basic daily activities of elderly people with dementia. It evaluates each activity in 3 stages: initiation, planning and organization, effective performance. Score 1 or 0 for each question. The higher the total score, the better the outcome. The total score is from 0 to 47.
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of Gait
Gait velocity will be assessed using the 8-meter walking time. Time for walking 8-m will be measured by a stopwatch. The faster of two trials will be used in the analysis The faster of the walking time the better outcome.
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of balance
Single leg stance time will be measured by asking individuals, with their hands on their hips, to balance as long as possible on one leg with an upper limit of 30 seconds. Two trials for each leg will be performed. The best time of the four trials will be used for analysis. The longer to time duration the better outcome.
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of Pulsatility Index
Pulsatility Index of Transcranial doppler ultrasound is a painless test that uses sound waves to detect medical problems that affect blood flow in your brain. It is a measure of vascular resistance of cerebral vessels. The higher the index means higher resistance and stiffness of blood vessels which lead to worse outcome. There is no minimum or maximum values available for this index.
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of Breath Holding Index
Breath Holding Index calculated based on the mean flow velocities of the middle cerebral artery using transcranial Doppler. It indicates the brain artery could react better to lowered oxygen level. The higher the index means better reaction to lowered oxygen level which leads to better outcome. There is no minimum or maximum values available for this index.
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of DNA methylation
blood biomarker. DNA methylation-derived epigenetic age clock is an indicator of biological aging.
Time frame: Baseline, week 12, week 26, week 52 and week 78
Change of neurovascular inflammation
blood biomarker to investigate neurovascular inflammation that induce neurodegeneration
Time frame: Baseline, week 12, week 26, week 52 and week 78
Plan to share: No
No publications or documents are linked to this record.
Started May 2022 (actual). Primary completion is estimated for May 2027, 60 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: GLP-1 Mimetic · Semaglutide
Cerebral Small Vessel Diseases →
Chinese University of Hong Kong →