* 4730 EVOKE -Semaglutide in people with early Alzheimer's disease
Research type
Research Study
Full title
A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer´s disease (EVOKE)
IRAS ID
294544
Contact name
Naji Tabet
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2020-004848-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Universal trial number, U1111-1259-2929
Duration of Study in the UK
4 years, 3 months, 3 days
Research summary
Research Summary: The Evoke study is a randomised, double-blind, placebo-controlled trial to evaluate how effective and safe oral semaglutide is in patients with early Alzheimer’s disease.
Alzheimer’s disease is a progressive disorder characterised by gradual cognitive and functional decline that ultimately leads to bodily dysfunction and death. Currently available treatments only provide symptomatic relief and there is a significant unmet need for treatments that can lower the rate of disease progression.
Oral semaglutide is a Glucagon like peptide 1 receptor agonist (GLP1-RA), which is already approved for the treatment of Type 2 diabetes in many countries including the UK. This study is being conducted to assess at the potential benefits for patients with Alzheimer’s disease.
Eligible patients will be randomised 1:1 to receive either semaglutide or placebo, both are to be administered orally once daily and added to standard patient care. Participants will require a study partner to attend some visits to share information about the participant and themselves.
The study duration is approximately 173 weeks; consisting of a 12-week screening period, followed by a 156-week randomised treatment period and a 5-week follow-up period. The study consists of at least 17 clinic visits (screening assessments may require more than 1 visit) and 1 phone call. The study plans to include 1840 participants across 37 countries. In the UK, the planned number of participants is 32 across 15 sites which will include both NHS and non-NHS sites. Qualitative interviews will be performed in approximately 45 trial participants(15 subjects and 30 study partners)across 3 countries including the UK to understand participants experience with the disease and prior treatments and to explore their expectations for this treatment and this trial.
Summary of results: The main purpose of the study was to learn about the effect of semaglutide in people with early Alzheimer’s disease.
The study was stopped early because the study drug was not found to have a positive effect on early Alzheimer’s disease.
The researchers did not find that semaglutide had a positive effect on Alzheimer’s disease, and the study was stopped early. The study found that in comparison with placebo, semaglutide led to a meaningful reduction in levels of a blood marker linked to inflammation, measured from the start of the study to week 104.It was also found that semaglutide taken by mouth was safe and generally well
tolerated in people with early Alzheimer’s disease, and its side effects were
similar to those already known from using thIn this study, researchers did not find that semaglutide had an effect on Alzheimer’s disease, and the study was stopped early.
These results are for this study only. Other studies may show different results.is medicine for other conditions.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0188
Date of REC Opinion
20 May 2021
REC opinion
Further Information Favourable Opinion