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Recruiting Phase 2

GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD)

NCT05356104 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2022-05-25
Last updated
2026-06-05

Condition(s) studied

Cerebral Small Vessel Disease

Investigational drug(s) / intervention(s)

GLP-1 receptor agonist

GLP-1 receptor agonist: 2mg once weekly via subcutaneous injection

Study 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 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Chinese ethnicity; 2. Age 55 to 80 years old; 3. Age-Related White Matter Change (ARWMC) Scale of 2 or early 3 in FLAIR MRI; 4. Modified Functional Ambulation Classification 5 or above; 5. Montreal Cognitive Assessment (MoCA) score \< 25; 6. Both diabetic and non-diabetic patient are eligible; 7. Patient who understands the purpose and requirements of the study, and able to provide an informed consent; Exclusion Criteria: 1. Dementia or MoCA score lower than 2nd percentile of the age and education adjusted cutoff ; 2. Cerebral white matter changes unrelated to neurodegenerative, e.g. CADASIL, X-linked adrenoleukodystrophy, metabolic diseases, multiple sclerosis, etc.; 3. 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; 4. BMI \<18.5kg/m2; 5. 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; 6. Medical condition that would not allow the patient to adhere to the protocol or complete the study.; 7. Patient with established neurodegenerative disorders (e.g. Parkinson's Disease, Alzheimer's Disease, etc.); 8. Pregnancy.

Primary outcome measure(s)

  • Change of Brain Peak Width of Skeletonized Mean Diffusivity — Baseline and week 78
    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.

Trial sites (2)

FacilityCityRegionStatus
First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting
Chinese University of Hong Kong Hong Kong Hong Kong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05356104 on ClinicalTrials.gov ↗ ← All trials in China