Status:
RECRUITING
GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD)
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Cerebral Small Vessel Disease
Eligibility:
All Genders
55-80 years
Phase:
PHASE2
Brief Summary
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 su...
Detailed Description
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" wi...
Eligibility Criteria
Inclusion
- Chinese ethnicity;
- Age 55 to 80 years old;
- Age-Related White Matter Change (ARWMC) Scale of 2 or early 3 in FLAIR MRI;
- Modified Functional Ambulation Classification 5 or above;
- Montreal Cognitive Assessment (MoCA) score \< 25;
- Both diabetic and non-diabetic patient are eligible;
- Patient who understands the purpose and requirements of the study, and able to provide an informed consent;
Exclusion
- Dementia or MoCA score lower than 2nd percentile of the age and education adjusted cutoff ;
- Cerebral white matter changes unrelated to neurodegenerative, e.g. CADASIL, X-linked adrenoleukodystrophy, metabolic diseases, multiple sclerosis, etc.;
- Contraindication to GLP-1R agonist, including thyroid carcinoma, pancreatic pathology, proliferative retinopathy, hypersensitivity to GLP-1R agonist and history of family history of multiple endocrine neoplasia;
- BMI \<18.5kg/m2;
- Contraindication to proposed imaging, e.g. chronic kidney disease (KDNIGO) stage 4 or above, acute kidney injury, hypersensitivity to gadolinium-based contrast, non-MRI conditional implants or prosthesis;
- Medical condition that would not allow the patient to adhere to the protocol or complete the study.;
- Patient with established neurodegenerative disorders (e.g. Parkinson's Disease, Alzheimer's Disease, etc.);
- Pregnancy.
Key Trial Info
Start Date :
May 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05356104
Start Date
May 25 2022
End Date
December 1 2026
Last Update
January 29 2025
Active Locations (1)
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1
Chinese University of Hong Kong
Hong Kong, Hong Kong