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NCT05891496CompletedPhase 3

A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease

A Randomised Double-blind Placebo-controlled Clinical Study Investigating the Effects of Semaglutide s.c. Once-weekly Versus Placebo on Central and Peripheral Inflammation in Participants With Alzheimer's Disease

Source: ClinicalTrials.gov · Last updated 18 Aug 2026

Brief summary (registry, in English)

The study is being conducted to understand how the medicine, semaglutide, affects the immune system and other biological processes in people with Alzheimer's disease. Semaglutide is a medicine that doctors can prescribe in some countries for the treatment of type 2 diabetes and excess body weight. This study will help us understand whether semaglutide can also be used for the treatment of Alzheimer's disease. The study will last for about 77 weeks. In the first 12 weeks of treatment, participants will either get semaglutide (active medicine) or placebo (inactive dummy medicine). Which treatment participants get is decided by chance. In the following 52 weeks of treatment, all participants taking part in the study will get semaglutide. Participants must have a study partner, who is willing to take part in the study. Participants will get study medicine in a pen injector. The study partner will need to inject the study medicine into the skin of participant's stomach, thigh or upper arm once every week.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
23 (actual)
First submitted
29 May 2023
Start date
20 Jun 2023
Primary completion date
19 Aug 2024
Lead sponsor
Novo Nordisk A/S
NCT number
NCT05891496
EudraCT number
2022-003384-24

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 23
  • From 20 Jun 2023 to the primary completion date, 19 Aug 2024
  • 12 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Brain magnetic resonance imaging (MRI) scan suggestive of clinically significant structural central nervous system (CNS) disease confirmed by local read (example cerebral large-vessel disease \[large vessel (cortical) infarcts greater than 10 millimeter (mm) in diameter\], prior macro-haemorrhage \[greater than 1centimeter cube (cm\^3)\], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus)
  • History or evidence of autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, lupus, glomerulonephritis, psoriasis (but not limited to): Any other medical condition that would require use of systemic corticosteroids or immunosuppressants or immunostimulants in the 12 months prior to screening (visit 1)
  • Received a vaccine product (including booster) 4 weeks prior to screening (visit 1) or expected to receive a vaccine product (including booster) before visit 5
  • Use of any systemic immunomodulating drugs (small molecules and/or biologics) in the last 12 months prior to screening (visit 1) or anticipated use of such drugs during study intervention period 1 (i.e., during the first 12 weeks of treatment until visit 5), such as corticosteroids for systemic use, immunostimulants and immunosuppressants

Other

  • Brain MRI scan suggestive of significant small vessel pathology confirmed by local read and defined as greater than 1 lacunar infarct and/or white matter hyperintensity (WMH) Fazekas13 scale greater than 2, (white matter \[WM\] greater than 20 mm) in the deep white matter and periventricular regions

Who the study is looking for

  • Male or female, aged 55-75 years (both inclusive) at the time of signing the informed consent
  • Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type according to the National Institute on Aging- Alzheimer's Association (NIA-AA) 2018 criteria
  • Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1)
  • Amyloid positivity established with either historical amyloid positron emission tomography (PET) or historical cerebrospinal fluid (CSF) Aβ1-42 or historical CSF Aβ1-42/Aβ1-40 (historical data within the last 5 years) or blood sample for amyloid biomarker (Aβ42/Aβ40 ratio and p-tau217/np-tau217 ratio) at screening (visit 1)
  • Treated with acetylcholinesterase inhibitors (approved for the treatment of Alzheimer's disease) and on stable dose for greater than 90 days before screening (visit 1)

Age in the registry: 55 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ottawa Memory Clinic
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Memory Program
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TorontoCanadaUnknown status
Centre de la Mémoire
Coordinator of this site? Confirm its status
GenevaSwitzerlandUnknown status
Rigshospitalet - afsnit 8015
Coordinator of this site? Confirm its status
København ØDenmarkUnknown status
Rigshospitalet - afsnit 8015 Hukommelsesklinikken
Coordinator of this site? Confirm its status
København ØDenmarkUnknown status
Azienda Ospedaliera Spedali Civili di Brescia
Coordinator of this site? Confirm its status
BresciaItalyUnknown status
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Coordinator of this site? Confirm its status
PerugiaItalyUnknown status
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser
Coordinator of this site? Confirm its status
PerugiaItalyUnknown status
Fondazione Santa Lucia IRCCS
Coordinator of this site? Confirm its status
RomaItalyUnknown status
Karolinska universitetssjukhuset - Huddinge
Coordinator of this site? Confirm its status
StockholmSwedenUnknown status
Brain Matters Research
Coordinator of this site? Confirm its status
Delray BeachUnited StatesUnknown status
Banner Sun Health Research Institute
Coordinator of this site? Confirm its status
Sun CityUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.