NCT07200622 · Phase 2 · NOT YET RECRUITING
Oral Semaglutide in Patients With Alzheimer's Disease
This Phase 2 trial is testing oral semaglutide (Rybelsus, a drug originally developed for type 2 diabetes) in people who already have mild Alzheimer's disease. Researchers want to know if it is safe and tolerable, and whether it changes synaptic density in the brain, measured by PET scan. Phase 2 means this is an early-stage test of whether it works and is safe — it is not proven or approved for Alzheimer's.
You may qualify if
- Capable of giving and capacity to give informed consent.
- An individual who can act as a reliable study partner with regular contact
- Diagnosis of Alzheimer's disease according to the revised NIA-AA criteria
- Age from 50 years
- Mini-Mental State Examination (MMSE) score of ≥18; likely complete all the assessments
- Rosen Modified Hachinski Ischemic score ≤4
- On stable medication for 2 months before the screening visit; on or off cholinesterase inhibitors
- Fluency in English and evidence of adequate premorbid intellectual functioning
- Likely to be able to participate in all scheduled evaluations and complete all required tests
You're excluded if
- Any contraindications to the use of oral semaglutide
- Significant neurological disease other than AD that may affect cognition
- MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDSAIREN criteria
- Current presence of a clinically significant major psychiatric disorder
- Current clinically significant systemic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study
- Myocardial infarction within the last 1 year
- Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the subject
- History of alcohol or drug dependence within the last 2 years
- Current use of narcotic medications which could affect cognition. Subjects on anticoagulants will be allowed, but will not have an arterial line inserted
- Women of childbearing potential. Women who could become pregnant will be required to use adequate contraception throughout the trial. Please see appendix A for more information. All women of childbearing potential will take a pregnancy test before the PET scan.
- Any contraindications to MRI scanning
- Any historical evidence of pancreatitis or gallstones as proven by ultrasound or medical admission.
- History of medullary thyroid cancer
- Patients diagnosed with T2DM who are unwilling to change their treatment to semaglutide.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-10-01