CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,840 enrolled
Drug / intervention
Semagludtide +1 moredrug
Likely dose
Semagludtide 14 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04777396
NCT04777396Phase 3Completed

A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)

Novo Nordisk A/S·interventional·Posted Mar 2, 2021·Updated Apr 9, 2026

In Brief

A Phase 3 clinical trial evaluating Semagludtide and Placebo (semaglutide) for Early Alzheimer's Disease. Completed, enrolled 1,840 participants across 444 sites in 37 countries.

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedMar 2, 2021
Enrollment StartMay 18, 2021
Primary CompletionSep 16, 2025
Study CompletionJan 30, 2026
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 5.3 years ago

Interventions

Semagludtidedrug

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