Semaglutide for Early Alzheimer's Disease

(EVOKE Plus Trial)

Recruiting at781 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

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.

Research Team

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

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

I am between 55 and 85 years old.

My Alzheimer's medication dose has been stable for 3 months.

I have mild dementia, with some difficulty in daily activities.

Exclusion Criteria

You have specific signs of stroke in a brain scan.

I do not have an active severe mental health condition.

I do not have a major neurological disorder besides mild Alzheimer's or MCI.

Treatment Details

Interventions

• Placebo (semaglutide) (Drug)
• Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist)

Trial Overview The EVOKE Plus study is testing Semaglutide against a placebo to see if it helps with early Alzheimer's disease symptoms. Over roughly 3 years, participants will visit clinics for tests and scans, including blood samples at some visits.

Participant Groups

Group I: Oral semaglutide Experimental Treatment 1 Intervention

Participants are given oral semaglutide once daily

Group II: Placebo (semaglutide) Placebo Group 1 Intervention

Participants are given oral placebo once daily

Semaglutide is already approved in Canada, Japan for the following indications:

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

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