* 4725 EVOKE plus-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 plus)

• IRAS ID

  294543

• Contact name

  Naji Tabet

• Contact email

  n.tabet@bsms.ac.uk

• Sponsor organisation

  Novo Nordisk A/S

• Eudract number

  2020-004864-25

• Clinicaltrials.gov Identifier

  NCT04777409

• Clinicaltrials.gov Identifier

  U1111-1259-2920, Universal trial number

• Duration of Study in the UK

  4 years, 3 months, 3 days

• Research summary

  The Evoke plus 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 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 39 countries. In the UK, the planned number of participants is 65 across 15 sites which will include both NHS and non-NHS sites.

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  22/YH/0187

• Date of REC Opinion

  20 May 2021

• REC opinion

  Further Information Favourable Opinion