2023-506825-13-00招募中3 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.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Change in gene expression assessed by single-cell ribonucleic acid sequencing (scRNAseq) (cells in CSF) from baseline (week 0) to visit 5 (week 12)
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
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 cerebrospinal fluid (CSF) Aβ1-42 or historical CSF Aβ1-42/Aβ1-40 (historical data within the last 5 years) or blood sample for amyloid biomarker (Aβ42/Aβ40 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)
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 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
结局指标
主要结局
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 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)
Change in gene expression assessed by scRNAseq (cells in blood) from baseline (week 0) to visit 5 (week 12)
次要结局
- Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to visit 5 (week 12)
- Number of treatment emergent adverse events (TEAEs) from baseline (week 0) to end of treatment (week 64)
- Weekly average semaglutide concentration (C avg) based on population pharmacokinetics (PK) analysis from visit 3 (week 4) to end of treatment (week 64)
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Research study to look at how well semaglutide works in people living with heart failure, obesity and type 2 diabetes.CTRI/2021/11/038164Novo Nordisk AS610
进行中（未招募）
1 期
Effect of treatment with Semaglutide on cognitive function, brain inflammation and nitrogen-conversion in the liver in patients with non-alcoholic steatohepatitis: A randomized placebo-controlled trialon-alcoholic steatohepatitisMedDRA version: 22.0Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2020-004373-50-DKAarhus University Hospital24
进行中（未招募）
3 期
STEP-1: Research study investigating how well semaglutide works in people suffering from overweight or obesityCTRI/2018/07/014765Novo Nordisk AS1,950
进行中（未招募）
1 期
Research study to investigate how well semaglutide works in people living with obesity and heart failureEUCTR2019-004452-11-CZovo Nordisk A/S516
进行中（未招募）
1 期
Research study to investigate how well semaglutide works in people living with obesity and heart failureHeart failure with preserved ejection fractionObesityMedDRA version: 20.1Level: LLTClassification code 10076396Term: Heart failure with preserved ejection fractionSystem Organ Class: 100000004849EUCTR2019-004452-11-HUovo Nordisk A/S516