Using GLP-1 analogue to prevent progression of small vessel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting
• Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Bonaventure Yiu Ming Ip, MBChB, PhD — Chinese University of Hong Kong
• Study coordinator: Bonaventure Yiu Ming Ip, MBChB, PhD
• Email: bonaventureip@cuhk.edu.hk
• Phone: 852-28902002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cerebral Small Vessel Disease Progression by Stroke Type

  This study tests whether CSVD progresses differently if a patient has a concurrent ischemic stroke, using MRI and blood biomarkers in adults.

  Recruiting University Hospital Ulm · Ulm, Baden-Wurttemberg · NCT07611136

• Brain activity and thinking problems in cerebral small vessel disease

  This project will see if EEG brain signals and home-based cognitive training or tACS can detect and improve thinking problems in older adults with cerebral small vessel disease.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07068620

• PUFFINS Brain Health Imaging

  This project will try lower-cost low-field, ultra-low-field, and field-cycling MRI scans alongside standard 3T MRI to image the brains of adults aged 50+ with cerebral small vessel disease who do not report memory problems.

  Recruiting at 2 sites University of Aberdeen · Aberdeen and 1 other locations · NCT06947876

• Edaravone Dexborneol sublingual tablets for acute small-vessel ischemic stroke

  This trial will test whether taking Edaravone Dexborneol sublingual tablets twice daily helps adults aged 30–80 who recently had a small subcortical ischemic stroke.

  Recruiting Phase 3 Peking Union Medical College Hospital · Beijing · NCT06674460

• Improving brain blood flow in patients with cerebral small vessel disease

  This study is testing if a new drug can improve blood flow in the brains of people with cerebral small vessel disease.

  Recruiting Imperial College London · London · NCT06643013

• Exploring the link between deep medullary veins and cognitive issues in small vessel disease

  This study is trying to see if changes in certain brain veins are linked to thinking problems in people with small vessel disease.

  Recruiting Zigong No.1 Peoples Hospital · Zigong, Sichuan · NCT05715710

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.