Inclusion criteria, exclusion criteria and study 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.