At a glance
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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)
In Brief
A Phase 3 clinical trial evaluating Semaglutide and Placebo (semaglutide) for Early Alzheimer´s Disease. Completed, enrolled 1,840 participants across 498 sites in 38 countries.
Signals
Detailed Summary
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease. Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance. The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken. Participants must have a study partner, who is willing to take part in the study. Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period. A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.
Study Details
Timeline
Arms & Interventions
Participants are given oral semaglutide once daily
Participants are given oral placebo once daily
Interventions
Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
Oral placebo (semaglutide) once-daily. The study will last for up to 173 weeks