Oral Semaglutide in Patients With Alzheimer's Disease

What Was Tested

The trial (phase 2) is built around Semaglutide.

Alzheimer's disease (AD) is a progressive neurodegenerative disease and a major global healthcare burden.

It had two arms (groups): Semaglutide (Rybelsus) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 60 planned participants were the target.

It was open to people of any sex aged from 50 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: any contraindications to the use of oral semaglutide; MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDSAIREN criteria; myocardial infarction within the last 1 year.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Semaglutide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-09-25 with completion listed for 2027-12-31.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 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).

It also tracked 1 secondary outcome, for example To evaluate the change in synaptic density using [18F] SynVesT-1 before and after treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Semaglutide in 60 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.