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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Ivan
Koychev
Ms
Hannah
Bass
+44 (0)1865 618291
hannah.bass@psych.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Alzheimer's disease
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
The lack of effective treatments for dementia remains one of the key challenges to modern medicine and society. Its leading cause is Alzheimer’s disease (AD), a condition where proteins (called amyloid and tau) build up in the brain causing inflammation and loss of nerve cells. This process begins decades before the first symptoms of dementia appear, offering an opportunity to stop it in its tracks with the right treatment.
Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are a class of medication used to treat type 2 diabetes and obesity. They have been shown to reduce the risk of heart attack, stroke, and kidney disease in people with diabetes, and in animal experiments, they have also been found to affect the mechanisms thought to be involved in AD.
This study aims to examine the effects of semaglutide (a GLP-1 RA tablet) on the build-up of AD proteins, brain inflammation and thinking ability in people thought to be at high risk of developing AD.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38908839/ (added 25/06/2024)
You can take part if:
You may not be able to take part if:
1. Diagnosis of dementia2. Treatment with a GLP-1 RA: current or in the past 6 months3. Women who are pregnant, breastfeeding or of childbearing potential (see Appendix D for definition)4. People with type 1 diabetes mellitus, secondary diabetes, or maturity-onset diabetes of the young (MODY)5. People with T2DM who have pre-proliferative or proliferative diabetic retinopathy, or diabetic maculopathy6. People with T2DM if the cap of 30% of participants with T2DM randomised has been met7. Poorly controlled T2DM, defined as HbA1c ≥10% (86 mmol/mol)8. Evidence of severe renal impairment or an estimated glomerular filtration rate (eGFR) derived from serum creatinine (using the simple CKD-EPI formula) of <30 ml/min/1.73 m²9. Evidence of hepatic cirrhosis as assessed by medical history10. A psychiatric condition which in the opinion of the investigator may affect the safety of the participant or the outcomes of the study.11. Any contraindication for MRI or PET scans, including but not limited to: MR-incompatible pacemakers, pregnancy, aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or auto-defibrillator, cochlear implant, ocular foreign body, recent carotid stent, CSF shunt, other implanted medical device, e.g., Swan Ganz catheter, insulin pump, as assessed by a standard pre-MRI questionnaire12. Participant with a life expectancy of fewer than 6 months13. Currently enrolled in another investigational device or drug study, or less than 30 days between randomisation and ending another investigational device or drug study or receiving other investigational treatment(s). Patients participating in a purely observational trial will not be excluded14. Presence or history of malignant neoplasm (other than basal or squamous cell skin cancer, in-situ carcinomas of the cervix, or in situ prostate cancer) within 5 years prior to the day of screening15. Lack of access to a suitable digital technology to allow remote cognitive testing (PC or tablet connected to the internet)16. Significant eye or hearing impairment that in the opinion of the investigator may affect study procedures17. People with the low-affinity binding variant of the rs6971 allele of the TSPO gene18. Known or suspected hypersensitivity to the trial product or related products19. Poor venous access or other contraindications that would make blood sampling difficult20. Participant that in the view of the investigator will experience significant distress in the event of a positive amyloid status disclosure. Such individuals will not undergo amyloid screening21. Diabetic individuals treated with sulphonylureas or insulin where dose adjustment as described in protocol is not possible for whatever reason22. Individuals with significant radiation exposure in the past year for whom in the opinion of the investigator the additional exposure will result in an unacceptable risk
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Ms
Hannah
Bass
+44 (0)1865 618291
hannah.bass@psych.ox.ac.uk
Dr
Ivan
Koychev
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Oxford and funded by Novo Nordisk.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
