A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide for immune system (general).

The study is being conducted to understand how the medicine, semaglutide, affects the immune system and other biological processes in people with Alzheimer's disease.

Semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight.

This study will help them understand whether semaglutide can also be used for the treatment of Alzheimer's disease.

It had two arms (groups): Study intervention period 1 (experimental) and Study intervention period 2 (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 23 actual participants took part.

It was open to people of any sex aged from 55 years up to 75 years.

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

Examples of who could join: Male or female, aged 55-75 years (both inclusive) at the time of signing the informed consent. Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type according to the National Institute on Aging- Alzheimer's Association (NIA-AA) 2018 criteria. Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1).

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: received a vaccine product (including booster) 4 weeks prior to screening (visit 1) or expected to receive a vaccine product (including booster) before visit 5.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The immune system (general) participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2023-06-20 with completion listed for 2024-08-19.

It ran at 12 sites in Italy (4), United States (2), Canada (2), Denmark (2), Sweden (1) and Switzerland (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Gene Expression Assessed by Single-cell Ribonucleic Acid Sequencing (scRNAseq) (Cells in Cerebrospinal Fluid [CSF]) (time frame: Baseline (week 0), week 12). Change in Gene Expression Assessed by scRNAseq (Cells in Blood) (time frame: Baseline (week 0), week 12).

It also tracked 3 secondary outcomes, for example Number of Treatment Emergent Adverse Events (TEAEs) and Number of TEAEs.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 23 people with immune system (general).

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, Immune system (general) research.