Semaglutide for Early Alzheimer's Disease
(EVOKE Plus Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
If you are taking an approved Alzheimer's treatment, you can continue as long as your dose has been stable for at least 3 months before the study and doesn't change during the study unless necessary.
Is semaglutide safe for humans?
How is the drug Semaglutide unique for treating early Alzheimer's disease?
Semaglutide is unique because it is a glucagon-like peptide-1 (GLP-1) analogue that may protect against Alzheimer's disease by enhancing autophagy (the body's way of cleaning out damaged cells) and inhibiting apoptosis (cell death). It is also notable for its once-weekly administration, which is different from many other treatments.15678
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for people aged 55-85 with early Alzheimer's, confirmed by specific tests. They must have certain cognitive scores and stable treatment if they're already on Alzheimer's medication. Participants need a study partner and can't join if pregnant or planning pregnancy during the trial.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either semaglutide or placebo for the duration of the study
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Participants continue to be monitored for changes in cognitive scores and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Placebo (semaglutide)
- Semaglutide
Semaglutide is already approved in European Union, United States, Canada, Japan for the following indications:
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Type 2 diabetes
- Cardiovascular disease
- Obesity
- Obesity
- Type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
Lars Fruergaard Jørgensen
Novo Nordisk A/S
Chief Executive Officer since 2017
MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark
Martin Holst Lange
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen