NCT04777409

A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,840 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Alzheimer´s Disease

Interventions

Type	Name	Description
DRUG	Semaglutide	Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
DRUG	Placebo (semaglutide)	Oral placebo (semaglutide) once-daily. The study will last for up to 173 weeks

Timeline

• Start date: 2021-05-18
• Primary completion: 2025-09-15
• Completion: 2026-01-30
• First posted: 2021-03-02
• Last updated: 2026-03-27

Locations

495 sites across 38 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Netherlands, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study