A research study looking at the effect of semaglutide on the immune system and other biological processes in people with Alzheimer’s disease

Phase 1

• Conditions: Mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer’s type; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2022-003384-24-DK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-31
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified