Impact of Semaglutide in Amyloid Positivity (ISAP)

Overview

ISAP examines the effects of oral semaglutide, a glucagon-like protein-1 receptor agonist used for diabetes, on the build-up of proteins in the brain characterising Alzheimer’s Disease (amyloid and tau), brain inflammation, and people’s memory and thinking abilities. People included in ISAP are at higher risk of developing Alzheimer’s Disease because of having the protein amyloid in their brains.

Design

One-year randomised, double-blind, placebo-controlled, parallel-group, superiority trial led through a collaboration between the Diabetes Trials Unit and the Department of Psychiatry at the University of Oxford, and the global healthcare company, Novo Nordisk. ISAP will recruit 88 volunteers with high brain amyloid (so-called ‘amyloid-positive’) currently living without dementia from 5 UK clinical sites in Oxford, London (Imperial College and University College), Exeter and Bristol.

Aims

Primary

• To explore the effect of semaglutide on the rate of accumulation of tau protein in the brain.

Secondary

• To explore other potential mechanisms of action and effects of semaglutide on the pathway for Alzheimer’s disease including neuroinflammation, biomarkers in blood for Alzheimer’s disease, memory, thinking ability, neurodegeneration, health-related quality of life, levels of physical activity, and circadian rhythms.