Protocol for a double-blind placebo-controlled randomised controlled trial assessing the impact of oral semaglutide in amyloid positivity (ISAP) in community dwelling UK adults

What Was Tested

Researchers studied Semaglutide in this clinical study publication.

The study was approved by the West Midlands-Edgbaston Research Ethics Committee (22/WM/0013).

The results of the study will be disseminated through scientific presentations and peer-reviewed publications.

Who Took Part

The abstract describes 88 individuals taking part.

PubMed indexes the participants as middle-aged adults and older adults, both men and women.

Up to 88 individuals aged ≥55 years with brain amyloid positivity as assessed by positron emission tomography (PET) or cerebrospinal fluid, and no or mild cognitive impairment, will be randomised.

People with the low-affinity binding variant of the rs6971 allele of the Translocator Protein 18 kDa (TSPO) gene, which can interfere with interpreting TSPO PET scans (a measure of neuroinflammation), will be excluded.At baseline, participants undergo tau, TSPO PET and MRI scanning, and provide data on physical activity and cognition.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

The individuals were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

Blinding on both sides kept the individuals and researchers unaware of who received Semaglutide.

A placebo (an inactive look-alike) gave the Semaglutide group a baseline to be compared against.

They will attend safety visits and provide blood samples to measure AD biomarkers at weeks 4, 8, 26 and 39.

All cognitive assessments are repeated at week 26.

The last study visit will be at week 52, when all baseline measurements will be repeated.

The primary end point is the 1-year change in tau PET signal.

What Was Measured

The subject headings attached to it are Alzheimer Disease, Brain, Glucagon-Like Peptides, Positron-Emission Tomography, Randomized Controlled Trials as Topic, tau Proteins and United Kingdom.

Author keywords: dementia, nuclear medicine and protocols & guidelines.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Semaglutide in 88 individuals.

The publication is from 2024 (BMJ open), a journal based in England.

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