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

Launched by NOVO NORDISK A/S · May 29, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how a medicine called semaglutide affects the immune system and other biological processes in people with Alzheimer's disease. Semaglutide is already used to help with diabetes and weight management, and researchers want to see if it can also help people with Alzheimer's. The study will last about 77 weeks. For the first 12 weeks, participants will either receive semaglutide or a placebo, which is like a sugar pill that doesn’t have any active medicine. After that, everyone in the study will receive semaglutide for 52 weeks. Participants will need a study partner to help administer the medicine using a pen injector once a week.

To be eligible for the study, participants must be between 55 and 75 years old and have mild cognitive impairment or mild dementia related to Alzheimer’s. They also need to have a specific score that measures their level of cognitive decline and prove they have certain biological markers related to Alzheimer’s. Some health conditions, like significant brain diseases or autoimmune disorders, may exclude someone from participating. Overall, this trial aims to explore a potential new treatment for Alzheimer's, and participants will contribute to important research that could help many others in the future.

Gender

ALL

Eligibility criteria

• 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