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

ConditionCerebral Small Vessel Disease

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age55-80

SponsorChinese University of Hong Kong

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;