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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.
Must not have
Evidence of a relevant neurological disorder other than MCI or mild dementia of the Alzheimer's type at screening, including but not limited to Parkinson's disease, Lewy body disease, frontotemporal dementia of any type, Huntington's disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, HIV (human immunodeficiency virus), learning disability, intellectual disability, hypoxic cerebral damage, or significant head trauma with loss of consciousness that led to persistent cognitive deficits
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to week 156
Awards & highlights
Pivotal Trial

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.
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.
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.
Select...
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.
Select...
My tests show amyloid buildup in my brain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have a major neurological disorder besides mild Alzheimer's or MCI.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dementia
Secondary study objectives
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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
2021
Completed Phase 4
~5160

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,560 Previous Clinical Trials
3,644,667 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
43,525 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
141 Previous Clinical Trials
1,354,073 Total Patients Enrolled

Media Library

Semaglutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04777409 — Phase 3
Mild Cognitive Impairment Research Study Groups: Oral semaglutide 14 mg, Placebo (semaglutide)
Mild Cognitive Impairment 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
~283 spots leftby Sep 2025
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