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Not yet recruitingPhase 2

Oral Semaglutide in Patients With Alzheimer's Disease

Evaluating the Effects of GLP-1 Analogue, Oral Semaglutide, in Patients With Alzheimer's Disease

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

NCT IDNCT07200622
Org study ID21HH7080

Timeline

Milestones

Study start2025-09-25estimated
Study first posted2025-10-01actual
Last update posted2025-10-01actual
Primary completion2027-12-31estimated
Study completion2028-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Alzheimer's / cognition

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

To 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 endpoint
Secondary/protocol endpoint/low confidence

To 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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.