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

What Was Tested

In this phase 3 trial, researchers set out to test Semaglutide.

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).

It had two arms (groups): Oral semaglutide (experimental) and Placebo (semaglutide) (placebo comparator).

Participants are given oral semaglutide once daily.

Participants are given oral placebo once daily.

The registry classes the interventions as drug.

Who Took Part

1840 actual participants took part.

It was open to people of any sex aged from 55 years up to 85 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent. MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria. RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to (≤) 85. MMSE (Mini-Mental State Examination) greater than or equal to (≥) 22. Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aβ1-42 or CSF Aβ1-42/Aβ1-40.

The full record lists 7 inclusion and 4 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

As a double-blind Semaglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2021-05-18 with completion listed for 2025-09-15.

It ran at 498 sites in United States (107), Japan (63), China (36), Canada (20), Russia (18) and United Kingdom (16).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score (time frame: From baseline (week 0) to week 104).

It also tracked 29 secondary outcomes, for example Extension phase: Change in the ADCS-ADL-MCI score, Main Phase: Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score, Extension Phase: Change in the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog-13) score, Main Phase: Change in the Montreal Cognitive Assessment (MoCA) score, Extension Phase: Change in the Montreal Cognitive Assessment (MoCA) score and Main Phase: Change in the Alzheimer's Disease Composite Score (ADCOMS).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Semaglutide in 1840 people.

With 1840 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.