A Research Study Looking at the Effect of Semaglutide on the Immune System and Other Biological Processes in People With Alzheimer's Disease
- Conditions
- Alzheimers Disease
- Registration Number
- NCT05891496
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria:<br><br> - Male or female, aged 55-75 years (both inclusive) at the time of signing the<br> informed consent<br><br> - Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type according<br> to the National Institute on Aging- Alzheimer's Association (NIA-AA) 2018 criteria<br><br> - Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1)<br><br> - Amyloid positivity established with either historical amyloid positron emission<br> tomography (PET) or historical cerebrospinal fluid (CSF) Aß1-42 or historical CSF<br> Aß1-42/Aß1-40 (historical data within the last 5 years) or blood sample for amyloid<br> biomarker (Aß42/Aß40 ratio and p-tau217/np-tau217 ratio) at screening (visit 1)<br><br> - Treated with acetylcholinesterase inhibitors (approved for the treatment of<br> Alzheimer's disease) and on stable dose for greater than 90 days before screening<br> (visit 1)<br><br>Exclusion Criteria:<br><br> - Brain magnetic resonance imaging (MRI) scan suggestive of clinically significant<br> structural central nervous system (CNS) disease confirmed by local read (example<br> cerebral large-vessel disease [large vessel (cortical) infarcts greater than 10<br> millimeter (mm) in diameter], prior macro-haemorrhage [greater than 1centimeter cube<br> (cm^3)], cerebral vascular malformations, cortical hemosiderosis, intracranial<br> aneurism(s), intracranial tumours, changes suggestive of normal pressure<br> hydrocephalus)<br><br> - Brain MRI scan suggestive of significant small vessel pathology confirmed by local<br> read and defined as greater than 1 lacunar infarct and/or white matter<br> hyperintensity (WMH) Fazekas13 scale greater than 2, (white matter [WM] greater than<br> 20 mm) in the deep white matter and periventricular regions<br><br> - History or evidence of autoimmune diseases such as inflammatory bowel disease,<br> rheumatoid arthritis, lupus, glomerulonephritis, psoriasis (but not limited to): Any<br> other medical condition that would require use of systemic corticosteroids or<br> immunosuppressants or immunostimulants in the 12 months prior to screening (visit 1)<br><br> - Received a vaccine product (including booster) 4 weeks prior to screening (visit 1)<br> or expected to receive a vaccine product (including booster) before visit 5<br><br> - Use of any systemic immunomodulating drugs (small molecules and/or biologics) in the<br> last 12 months prior to screening (visit 1) or anticipated use of such drugs during<br> study intervention period 1 (i.e., during the first 12 weeks of treatment until<br> visit 5), such as corticosteroids for systemic use, immunostimulants and<br> immunosuppressants
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in gene expression assessed by single-cell ribonucleic acid sequencing (scRNAseq) (cells in cerebrospinal fluid [CSF]);Change in gene expression assessed by scRNAseq (cells in blood)
- Secondary Outcome Measures
Name Time Method Number of treatment emergent adverse events (TEAEs);Number of treatment emergent adverse events (TEAEs);Weekly average semaglutide concentration (Cavg) based on population pharmacokinetic (PK) analysis