A research study looking at the effect of semaglutide on the immune system and other biological processes in people with Alzheimer's disease
- Conditions
- Mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer’s typeMedDRA version: 20.0Level: LLTClassification code: 10001896Term: Alzheimer's disease Class: 10029205Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- CTIS2023-506825-13-00
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 21
Male or female, aged 55-75 years (both inclusive) at the time of signing the informed consent, MCI or mild dementia of the Alzheimer’s type according to the 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) Aß1-42 or historical CSF Aß1-42/Aß1-40 (historical data within the last 5 years) or blood sample for amyloid biomarker (Aß42/Aß40 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 > 90 days before screening (visit 1)
Brain magnetic resonance imaging (MRI) scan suggestive of clinically significant structural central nervous system (CNS) disease confirmed by local read (e.g., cerebral large-vessel disease [large vessel (cortical) infarcts >10 mm in diameter], prior macro-haemorrhage [>1 cm3 ], 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 >1 lacunar infarct and/or white matter hyperintensity (WMH) Fazekas scale >2, (WM >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo on central and peripheral inflammation in participants with Alzheimer’s disease;Secondary Objective: To compare the effects of semaglutide s.c. 1.0 mg once-weekly versus placebo on safety and tolerability in participants with Alzheimer’s disease, To evaluate the effects of semaglutide s.c. 1.0 mg once-weekly on safety and tolerability in participants with Alzheimer’s disease, To evaluate the steady state pharmacokinetics of semaglutide s.c. 1.0 mg once-weekly in participants with Alzheimer’s disease;Primary end point(s): Change in gene expression assessed by single-cell ribonucleic acid sequencing (scRNAseq) (cells in CSF) from baseline (week 0) to visit 5 (week 12), Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to visit 5 (week 12)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to visit 5 (week 12);Secondary end point(s):Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to end of treatment (week 64);Secondary end point(s):Weekly average semaglutide concentration (C avg) based on population pharmacokinetics (PK) analysis from visit 3 (week 4) to end of treatment (week 64)