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Glucagon-like peptide-1 (GLP-1) receptor agonist

Semaglutide for Early Alzheimer's Disease

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, aged 55-85 years at the time of signing informed consent
Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aβ1-42 or CSF Aβ1-42/Aβ1-40.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to week 156
Awards & highlights

Study Summary

This trial is to test whether the medication semaglutide has a positive effect on early Alzheimer's disease. The study will last for up to 173 weeks, and participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans, and at 10 of the clinic visits participants will have blood samples taken. The trial is only for women.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While the side effects of Semaglutide in this context aren't detailed here, generally it may cause digestive issues, changes in appetite, risk of low blood sugar levels (in diabetics), and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 55 and 85 years old.
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My tests show amyloid buildup in my brain.
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I have mild dementia, with some difficulty in daily activities.
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I am between 55 and 85 years old.
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My tests show amyloid buildup in my brain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline (week 0) to week 156
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to week 156 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dementia
Secondary outcome measures
Change in high sensitivity C-reactive protein level
Change in the 10-item Neuropsychiatric Inventory (NPI) score
Alzheimer's Disease
+13 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oral semaglutide 14 mgExperimental Treatment1 Intervention
Participants are given oral semaglutide once daily
Group II: Placebo (semaglutide)Placebo Group1 Intervention
Participants are given oral placebo once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,513 Previous Clinical Trials
2,413,189 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
43,280 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
105 Previous Clinical Trials
137,949 Total Patients Enrolled

Media Library

Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04777409 — Phase 3
Alzheimer's Disease Research Study Groups: Oral semaglutide 14 mg, Placebo (semaglutide)
Alzheimer's Disease Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT04777409 — Phase 3
Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04777409 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is Semaglutide most commonly prescribed?

"Semaglutide can help patients manage their weight, follow a reduced-calorie diet, and exercise regularly."

Answered by AI

Is this a new clinical trial?

"Novos Nordisk A/S sponsored the first trial for Semaglutide in 2018 which completed Phase 4 drug approval stage. This study involved 1387 patients and was conducted across 55 countries and 766 cities. Since then, 124 more trials have been completed."

Answered by AI

Are people still being accepted into this experiment?

"Yes, this information is accurate according to the website clinicaltrials.gov. The trial was posted on May 18th, 2021 and edited for the last time on November 15th, 2022."

Answered by AI

Does Semaglutide have any life-threatening side effects?

"Semaglutide has received a score of 3 from our team at Power. This is because Phase 3 trials have found some evidence of efficacy and multiple rounds of data support its safety."

Answered by AI

Is this a geriatric trial or are younger adults being accepted as well?

"The minimum age requirement to enroll in this clinical trial is 55, while the oldest eligible age is 85."

Answered by AI

Does Semaglutide have a long and successful research history?

"Currently, 59 different clinical trials are studying Semaglutide with 27 of them being in the third stage. Although a majority of these investigations are happening in Loma Linda, California; 3899 other sites around the world are also conducting research on Semaglutide."

Answered by AI

How many people fit the qualifications for this experiment?

"Yes. The online clinicaltrial registry shows that this research is open for recruitment and has been since 18th May 2021. The most recent update was on 15th November 2022. There are 95 sites taking part in the trial and they aim to recruit 1840 patients in total."

Answered by AI

How can I become a candidate for this research project?

"This study is looking for 1840 participants between the ages of 55 and 85 who have Alzheimer's disease. In addition to this, patients must meet the following criteria: CDR (Clinical Dementia Rating) global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home & hobbies, community affairs) Or CDR global score of 1.0, MMSE (Mini-Mental State Examination) greater than or equal to 22, RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index"

Answered by AI

Who else is applying?

What state do they live in?
Maine
Florida
Other
Colorado
How old are they?
18 - 65
65+
What site did they apply to?
Novo Nordisk Investigational Site
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Interested in helping with any research benefiting women’s health. This condition runs in my family, personally for me I notice myself forgetfulness ie cell phone keys wallet.
PatientReceived no prior treatments
~566 spots leftby Sep 2025