Using GLP-1 analogue to prevent progression of small vessel disease
GLP-1 Analogue in Preventing Progression of Small Vessel Disease (GAPP-SVD) - A Pilot Study
This study is testing if a new medication can help people with moderate-to-severe small vessel disease in the brain slow down its progression compared to standard treatment alone.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05356104 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of a GLP-1 receptor agonist, exenatide, in patients with moderate-to-severe cerebral small vessel disease (cSVD). The study involves 110 participants who will be randomized into two groups: one receiving the GLP-1R agonist along with standard medical therapy, and the other receiving standard therapy alone. Over a period of 78 weeks, various clinical, imaging, and sonographic parameters will be assessed to evaluate the treatment's impact on cSVD progression. The trial aims to provide insights into a potential new therapeutic approach for this condition.
Who should consider this trial
Good fit: Ideal candidates are Chinese individuals aged 55 to 80 with moderate-to-severe cSVD as indicated by specific MRI criteria.
Not a fit: Patients with dementia or other specific contraindications to GLP-1R agonists will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could help slow or prevent the progression of cerebral small vessel disease and its associated cognitive decline.
How similar studies have performed: While GLP-1R agonists have shown promise in cellular and animal studies, their application in cSVD patients is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hong Kong
- Chinese University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Bonaventure Yiu Ming Ip, MBChB — Chinese University of Hong Kong
- Study coordinator: Pauline Kwan, Master
- Email: paulinekwan@cuhk.edu.hk
- Phone: +85226352160
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.