Clinical trial

Oral Semaglutide in Patients With Alzheimer's Disease

Opening soon · Phase 2 · 0 countries · Registry ID NCT07200622

Opening soonPhase 2Interventional

What this study is about

Alzheimer's disease (AD) is a progressive neurodegenerative disease and a major global healthcare burden. Currently, the disease is only treated symptomatically and an effective disease-modifying therapy (DMT) that may slow the disease progression, and prevent cognitive and functional deterioration, is yet to emerge. Glucagon-like peptide-1 (GLP-1) analogues are being studied to treat neurodegenerative diseases, due to evidence of their neuroprotective effects in mouse models of AD. This study investigates Semaglutide, a modified human GLP-1RA in Alzheimer's disease to understand the mechanism of the disease. The primary objective of this study is to evaluate the safety and tolerability of oral semaglutide in individuals with mild AD. Moreover, the secondary objective of the study is to evaluate the change in synaptic density using PET before and after treatment with semaglutide.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age50 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionAlzheimer Disease

Full registry criteria

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.

Treatments and study arms

Semaglutide (Rybelsus®)

Drug

All subjects will receive oral semaglutide once daily (4-weekly dose escalation from 3 mg to 7 mg and finally 14 mg). This dose escalation schedule is specified in the IMP (Rybelsus) SmPC.

Placebo

Drug

Matched oral Placebo to be taken once daily.

Primary outcomes

To evaluate the safety and tolerability of oral semaglutide in an AD population.Adverse events monitoring: Baseline; Weeks 4, 8, 26, 39, 52

To assess the safety and tolerability of (1-year) Semaglutide treatment in patients with AD using composite outcome measure of the adverse events evaluated from the safety assessments. This will be assessed by the number of participants using a composite measure generated from abnormal vital signs, abnormal 12-lead ECG readings, abnormal laboratory (blood) tests, abnormalities found in MRI scans, abnormal physical exam findings, and abnormal neurological/psychiatric evaluation.

Study locations

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No public site location was included in this record. Check the original registry for updates.