Mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer’s type MedDRA version: 20.0 Level: LLT Classification code 10001896 Term: Alzheimers disease System Organ Class: 100000004852
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 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). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 7 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17
Exclusion criteria
Exclusion criteria: - 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 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 >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): o 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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): Co-primary: - Change in gene expression assessed by scRNAseq (cells in CSF) - Change in gene expression assessed by scRNAseq (cells in blood);Timepoint(s) of evaluation of this end point: From baseline (week 0) to visit 5 (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of treatment emergent adverse events (TEAEs) 2. Number of treatment emergent adverse events (TEAEs) 3. Weekly average semaglutide concentration (Cavg) based on population PK analysis;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to visit 5 (week 12) 2. From baseline (week 0) to end of treatment (week 64) 3. From visit 3 (week 4) to end of treatment (week 64) | — |
Countries
Canada, Denmark, European Union, Italy, Sweden, Switzerland, United States
Contacts
Public ContactClinical Transparency (2834)
Novo Nordisk A/S
Outcome results
None listed