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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
Amyloid positivity established with either amyloid PET (positron emission tomography), CSF (cerebrospinal fluid) Aβ1-42 or CSF Aβ1-42/Aβ1-40
Male or female, aged 55-85 years at the time of signing informed consent
Must not have
Evidence of a relevant neurological disorder other than MCI or mild dementia of the Alzheimer's type at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline (week 0) to week 156
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether semaglutide has a positive effect on early Alzheimer's disease by comparing it to a placebo. There will be 17 clinic visits and 1 phone call with the study doctor, and various tests and scans will be performed. The study will last for up to 173 weeks.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects of semaglutide in this context aren't detailed here, common ones from other studies include digestive issues like nausea or diarrhea, potential low blood sugar levels, headache, fatigue, and allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a neurological disorder that is not mild cognitive impairment or mild Alzheimer's.

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
Change in the ADCS-ADL-MCI (Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment ) score
+10 more

Side effects data

From 2018 Phase 3 trial • 458 Patients • NCT03015220
26%
Nasopharyngitis
9%
Constipation
7%
Influenza
5%
Diabetic retinopathy
5%
Nausea
4%
Gastrooesophageal reflux disease
3%
Back pain
3%
Upper respiratory tract inflammation
2%
Abdominal discomfort
2%
Vomiting
2%
Diarrhoea
1%
Cardiac ablation
1%
Herpes zoster
1%
Ischaemic cerebral infarction
1%
Acute myocardial infarction
1%
Appendicitis
1%
Large intestine polyp
1%
Peritonitis
1%
Sudden hearing loss
1%
Rectal adenocarcinoma
1%
Spinal operation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Semaglutide 3 mg
Oral Semaglutide 7 mg
Oral Semaglutide 14 mg
Dulaglutide 0.75 mg

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 SemaglutideExperimental Treatment1 Intervention
Participants are given oral semaglutide once daily
Group II: Placebo (semagludtide)Placebo Group1 Intervention
Participants are given oral placebo once daily

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,557 Previous Clinical Trials
2,444,470 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
139 Previous Clinical Trials
153,977 Total Patients Enrolled
Clinical Transparency (Dept. 2834)Study DirectorNovo Nordisk A/S
3 Previous Clinical Trials
1,009 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
57 Previous Clinical Trials
43,525 Total Patients Enrolled

Media Library

Placebo (semaglutide) Clinical Trial Eligibility Overview. Trial Name: NCT04777396 — Phase 3
Alzheimer's Disease Research Study Groups: Placebo (semagludtide), Oral Semaglutide
Alzheimer's Disease Clinical Trial 2023: Placebo (semaglutide) Highlights & Side Effects. Trial Name: NCT04777396 — Phase 3
Placebo (semaglutide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04777396 — Phase 3
~283 spots leftby Sep 2025
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