Could a diabetes drug tame Alzheimer's inflammation?
NCT ID NCT05891496
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study looked at whether semaglutide, a medicine used for diabetes and weight loss, can reduce inflammation in the brain and body of people with early Alzheimer's disease. Twenty-three participants with mild memory problems or mild dementia received either semaglutide or a placebo for 12 weeks, then all received semaglutide for another 52 weeks. The goal was to see how the drug affects immune system activity, not to cure the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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23 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Sep 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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) Exclusion Criteria: * 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) * 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
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Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser
Perugia, 06132, Italy
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Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
Perugia, 06132, Italy
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Banner Sun Health Research Institute
Sun City, Arizona, 85351, United States
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Brain Matters Research
Delray Beach, Florida, 33445, United States
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Centre de la Mémoire
Geneva, 1205, Switzerland
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Fondazione Santa Lucia IRCCS
Roma, 00179, Italy
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Karolinska Universitetssjukhuset, Huddinge
Stockholm, 141 86, Sweden
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Memory Program
Toronto, Ontario, M3B2S7, Canada
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Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3, Canada
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Rigshospitalet - afsnit 8015
København Ø, 2100, Denmark
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Rigshospitalet - afsnit 8015 Hukommelsesklinikken
København Ø, 2100, Denmark
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Other studies related to the condition(s) this trial covers.
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- Can a new pill change the Brain's activity in early Alzheimer's?
- Can Real-World data uncover hidden risks of the Alzheimer's drug LEQEMBI?
- Nasal spray could tame brain inflammation in early Alzheimer's
- New drug aims to stop Alzheimer's before it starts in gene carriers