EUCTR2022-003384-24-DK进行中（未招募）1 期
A randomised double-blind placebo-controlled clinical study investigating the effects of semaglutide s.c. once-weekly versus placebo on central and peripheral inflammation in participants with Alzheimer’s disease
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- 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
排除标准
- •- 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.
研究者
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