Oral Semaglutide in Patients With Alzheimer's Disease
- Status
- Not yet recruitingResults none
- Why it is watched
- non-weight indication: alzheimers
- Who it enrolls
- age 50 Years to no upper limit; no BMI minimum stated; conditions: Alzheimer Disease
- Interventions
- Semaglutide (Rybelsus®); Placebo
- Conditions
- Alzheimer Disease
- Phase and size
- Phase 2 · 60 participants
- Dates
- Start 2025-09-25
Primary completion 2027-12-31 - Sponsor
- Imperial College London (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- To evaluate the safety and tolerability of oral semaglutide in an AD population.Adverse events monitoring: Baseline; Weeks 4, 8, 26, 39, 52
02Eligibility
Who can take part
Inclusion Criteria: 1. Capable of giving and capacity to give informed consent. 2. An individual who can act as a reliable study partner with regular contact 3. Diagnosis of Alzheimer's disease according to the revised NIA-AA criteria 4. Age from 50 years 5. Mini-Mental State Examination (MMSE) score of ≥18; likely complete all the assessments 6. Rosen Modified Hachinski Ischemic score ≤4 7. On stable medication for 2 months before the screening visit; on or off cholinesterase inhibitors 8. Fluency in English and evidence of adequate premorbid intellectual functioning 9. Likely to be able to participate in all scheduled evaluations and complete all required tests Exclusion Criteria: 1. Any contraindications to the use of oral semaglutide 2. Significant neurological disease other than AD that may affect cognition 3. MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDSAIREN criteria 4. Current presence of a clinically significant major psychiatric disorder 5. 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 6. Myocardial infarction within the last 1 year 7. Other clinically significant abnormality on physical, neurological or laboratory examination that could compromise the study or be detrimental to the subject 8. History of alcohol or drug dependence within the last 2 years 9. Current use of narcotic medications which could affect cognition. Subjects on anticoagulants will be allowed, but will not have an arterial line inserted 10. 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. 11. Any contraindications to MRI scanning 12. Any historical evidence of pancreatitis or gallstones as proven by ultrasound or medical admission. 13. History of medullary thyroid cancer 14. Patients diagnosed with T2DM who are unwilling to change their treatment to semaglutide.
03Change log
Registry changes
No changes recorded since the trial was added.