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Oral Semaglutide for Alzheimer's Disease

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What is being tested

Semaglutide (Rybelsus®)

+ Placebo

Drug
Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

Over 50 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: September 2025
See protocol details

Summary

Principal SponsorImperial College London
Study ContactPaul Edison, MD, PhD, FRCP, FRCPI
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 25, 2025

Actual date on which the first participant was enrolled.

This study focuses on Alzheimer's disease, a condition that progressively affects the brain, leading to memory loss and cognitive decline. Currently, treatments only address symptoms but do not stop the disease's progression. Researchers are now looking into a medication called Semaglutide, which belongs to a group of drugs known as GLP-1 analogues. These drugs have shown protective effects on brain cells in animal studies. The study aims to explore how Semaglutide might work in humans with Alzheimer's and to assess its safety and how well people can tolerate it. This research is important because it could lead to a treatment that not only alleviates symptoms but also slows down the disease's progression. Participants in the study will take Semaglutide in pill form. Researchers will closely monitor their health to ensure the drug is safe and well-tolerated. To measure the effectiveness of Semaglutide, the study will use a special type of scan called PET to look at the brain before and after treatment. This scan will help determine if there are any changes in synaptic density, which relates to how brain cells communicate with each other. Understanding these changes can provide insights into how the drug might impact Alzheimer's disease, potentially leading to new treatment methods.

Official TitleEvaluating the Effects of GLP-1 Analogue, Oral Semaglutide, in Patients With Alzheimer's Disease
NCT07200622
Principal SponsorImperial College London
Study ContactPaul Edison, MD, PhD, FRCP, FRCPI
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

Criteria

9 inclusion criteria required to participate
Capable of giving and capacity to give informed consent.

An individual who can act as a reliable study partner with regular contact

Diagnosis of Alzheimer's disease according to the revised NIA-AA criteria

Age from 50 years

Show More Criteria

14 exclusion criteria prevent from participating
Any contraindications to the use of oral semaglutide

Significant neurological disease other than AD that may affect cognition

MRI/CT showing unambiguous aetiological evidence of cerebrovascular disease with regard to their dementia or vascular dementia fulfilling NINCDSAIREN criteria

Current presence of a clinically significant major psychiatric disorder

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
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Oral Semaglutide for Alzheimer's Disease | PatLynk