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

NCT04777396 · Completed

Last updated 2026-05-28

This clinical trial is testing the effects of the medication semaglutide in adults with early Alzheimer's disease to see how it may impact their memory and thinking abilities.

Status Completed The study has finished.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 1,840 people

Who can join Ages 55–85 · all sexes

Timeline Started 2021-05 · est. completion 2026-01

Where 444 sites · Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT04777396 ↗

Description as written by the study sponsor.

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.

Treatments tested

Semagludtide Drug

Oral semaglutide once-daily, dose gradually increased to 14 mg. The study will last for up to 173 weeks
Placebo (semaglutide) Drug

Oral placebo (semaglutide) once-daily, The study will last for up to 173 weeks

Main thing measured	Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score
Sponsor	Novo Nordisk A/S
Conditions studied	Early Alzheimer's Disease
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04777396 ↗