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

  • End date
    Dec 27, 2026
  • participants needed
  • sponsor
    Chinese University of Hong Kong
Updated on 4 October 2022


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 exenatide, a 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

Condition Cerebral Small Vessel Disease
Treatment Exenatide extended release
Clinical Study IdentifierNCT05356104
SponsorChinese University of Hong Kong
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

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 Criteria

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.)
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