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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
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
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 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.Check my eligibility
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.See study design
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
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I have mild dementia, with some difficulty in daily activities.
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My tests show amyloid buildup in my brain.
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My Alzheimer's medication dose has been stable for 3 months.
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I am between 55 and 85 years old.
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I have mild dementia, with some difficulty in daily activities.

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
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%
Upper respiratory tract inflammation
3%
Back pain
2%
Vomiting
2%
Diarrhoea
2%
Abdominal discomfort
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

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
1,503 Previous Clinical Trials
2,383,974 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
93 Previous Clinical Trials
108,580 Total Patients Enrolled
Clinical Transparency (Dept. 2834)Study DirectorNovo Nordisk A/S
2 Previous Clinical Trials
953 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

Frequently Asked Questions

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

Are there other examples of research done on Semagludtide?

"Semagludtide was first trialed in 2018 at Novo Nordisk Investigational Site. To date, there have been 123 completed studies. There are presently 59 studies underway, a considerable number of which are taking place in Phoenix, Arizona."

Answered by AI

What are some common conditions that doctors often treat with Semagludtide?

"Semagludtide can help patients struggling with weight management, calorie restriction, and lack of exercise."

Answered by AI

Is there a history of negative side effects with Semagludtide?

"Semagludtide was given a safety score of 3. This is because it is a phase 3 trial, meaning that there is both efficacy and safety data available from multiple rounds of testing."

Answered by AI

Is the age limit for this clinical trial set at 75 years or younger?

"This particular study is only for patients aged 55 to 85 years old. In contrast, there are 26 trials for people who are under 18 and 595 trials for patients that are over 65."

Answered by AI

What makes this clinical experiment innovative?

"Semagludtide has been under medical scrutiny since 2018. The first trial was completed in that same year and was sponsored by Novo Nordisk A/S. The trial included 1387 patients. Semagludtide received Phase 4 drug approval after the first study in 2018. As of now, there are 59 active trials in 711 cities and 55 countries."

Answered by AI

What is the projected intake for this experiment?

"That is correct, an updated posting on clinicaltrials.gov shows that this research is recruiting patients. The study was first published on May 18th, 2021 and the most recent edit was on March 30th, 2022. Up to 1840 patients can be enrolled at 66 sites."

Answered by AI

Are people with the disease currently being enrolled in this research program?

"The most recent information available on clinicaltrials.gov suggests that this study is still recruiting patients. The trial was initially posted on May 18th, 2021 and was updated as recently as March 30th, 2022."

Answered by AI

To whom does this opportunity for testing extend?

"This clinical trial is looking for 1840 participants aged 55-85 who have Alzheimer's disease. Patients must also meet the following criteria: MMSE (Mini-Mental State Examination) greater than or equal to 22, 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, RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed memory index score of below or equal to"

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
Colorado
Other
Florida
How old are they?
18 - 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?

My husband had a form of Alzheimers, and I would like to help find a cure for that terrible disease.
PatientReceived 2+ prior treatments
Both of my parents were diagnosed with Alzheimer's Disease, as well as 1 Grandparent, 2 Uncles, an Aunt and 2 cousins on my Mother's side of the family; and both Grandparents, an Aunt and an Uncle on my Father's side of the family. I would like to help eliminate Alzheimer's Disease in any way that I can!
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Is there a study site in Richmond, Virginia?
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novo Nordisk Investigational Site: < 48 hours
Average response time
  • < 2 Days
~602 spots leftby Sep 2025