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Oral Semaglutide in Patients With Alzheimer's Disease
Evaluating the Effects of GLP-1 Analogue, Oral Semaglutide, in Patients With Alzheimer's Disease
Lead sponsor
Asset
Semaglutide
Oral · GLP-1 agonist
Listed sites
0
Recruiting sites
—
Enrollment
60
estimated
Study population
Alzheimer's / cognition
Key I/E criterion
—
Primary endpoint
•Safety and tolerability of oral semaglutide in an AD population (Treatment-emergent AEs (any))
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
1 endpointTo evaluate the safety and tolerability of oral semaglutide in an AD population.
Time frame:Adverse events monitoring: Baseline; Weeks 4, 8, 26, 39, 52
composite event, event
componentsTreatment-emergent AEs (any)
Other (unclassified)
1 endpointTo evaluate the change in synaptic density using [18F] SynVesT-1 before and after treatment.
Time frame:[18F] SynVesT-1 PET will be conducted at baseline and Week 52 (end of treatment).
change from baseline, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.