Semaglutide for Early Alzheimer's Disease

(EVOKE Trial)

Recruiting at700 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

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

The EVOKE trial is for people aged 55-85 with early Alzheimer's, having an MMSE score of ≥22 and specific memory index scores. They must have stable Alzheimer's medication for 3 months if applicable, and show amyloid presence via PET or CSF tests. A study partner is required. Pregnant women or those planning pregnancy are excluded.

Inclusion Criteria

My tests show amyloid buildup in my brain.

You scored 22 or higher on the Mini-Mental State Examination.

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

Exclusion Criteria

A brain scan shows signs of specific types of strokes confirmed by a specialist.

I have a neurological disorder that is not mild cognitive impairment or mild Alzheimer's.

You have a serious mental health condition that is not stable.

Treatment Details

Interventions

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

Trial Overview Semaglutide's effect on early Alzheimer’s disease is being tested against a placebo over approximately 3 years with clinic visits and one phone call. Participants will undergo various tests, scans, and blood samples to assess the medicine's impact.

Participant Groups

Group I: Oral Semaglutide Experimental Treatment 1 Intervention

Participants are given oral semaglutide once daily

Group II: Placebo (semagludtide) Placebo Group 1 Intervention

Participants are given oral placebo once daily

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