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

NCT04777409 · Completed

Last updated 2026-05-28

This clinical trial is testing the effects of semaglutide, a medication, 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 495 sites · 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, United States

What this study is testing ClinicalTrials.gov NCT04777409 ↗

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

Semaglutide 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 NCT04777409 ↗