Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK
Department of Neurology, Radboudumc, Nijmegen, The Netherlands.
BMJ Open. 2024 Feb 26;14(2):e084303. doi: 10.1136/bmjopen-2024-084303.
The INflammation and Small Vessel Disease (INSVD) study aims to investigate whether peripheral inflammation, immune (dys)regulation and blood-brain barrier (BBB) permeability relate to disease progression in cerebral small vessel disease (SVD). This research aims to pinpoint specific components of the immune response in SVD relating to disease progression. This could identify biomarkers of SVD progression, as well as potential therapeutic targets to inform the development and repurposing of drugs to reduce or prevent SVD, cognitive decline and vascular dementia.
INSVD is a prospective observational multicentre cohort study in individuals with symptomatic SVD. This longitudinal study combines comprehensive immunophenotyping of the peripheral blood immune compartment with advanced neuroimaging markers of SVD and BBB permeability. The main SVD marker of interest is white matter microstructure as determined by diffusion tensor imaging, a valuable marker of disease progression owing to its sensitivity to early alterations to white matter integrity. The research is being conducted in two sites-in the UK (Cambridge) and the Netherlands (Nijmegen)-with each site recruiting 100 participants (total n=200). Participants undergo clinical and cognitive assessments, blood draws, and brain MRI at baseline and 2-year follow-up.
This study received ethical approval from the local ethics boards (UK: East of England-Cambridge Central Research Ethics Committee (REC) ref: 22/EE/00141, Integrated Research Application System (IRAS) ID: 312 747. Netherlands: Medical Research Ethics Committee (MREC) Oost-Nederland, ref: 2022-13623, NL-number: NL80258.091.22). Written informed consent was obtained from all subjects before the study. Any participant-derived benefits resulting from this research, such as new insights into disease mechanisms or possible novel therapies, will be disseminated to study participants, patient groups and members of the public.
NCT05746221.
INflammation 和 Small Vessel Disease（INSVD）研究旨在探讨外周炎症、免疫（失调）和血脑屏障（BBB）通透性是否与脑小血管疾病（SVD）的疾病进展有关。本研究旨在确定与 SVD 疾病进展相关的 SVD 中特定免疫反应成分。这可以确定 SVD 进展的生物标志物，以及潜在的治疗靶点，为开发和重新利用药物以减少或预防 SVD、认知能力下降和血管性痴呆提供信息。
INSVD 是一项针对有症状 SVD 患者的前瞻性观察性多中心队列研究。这项纵向研究将外周血免疫区的综合免疫表型与 SVD 和 BBB 通透性的先进神经影像学标志物相结合。感兴趣的主要 SVD 标志物是通过弥散张量成像确定的白质微观结构，这是一种有价值的疾病进展标志物，因为它对白质完整性的早期改变敏感。该研究在英国（剑桥）和荷兰（奈梅亨）的两个地点进行，每个地点招募 100 名参与者（共 200 名参与者）。参与者在基线和 2 年随访时接受临床和认知评估、血液采集和脑部 MRI。
这项研究得到了当地伦理委员会的批准（英国：东英格兰剑桥中央研究伦理委员会（REC）参考号：22/EE/00141，综合研究应用系统（IRAS）ID：312 747。荷兰：医学伦理委员会（MREC）东荷兰，参考号：2022-13623，NL 编号：NL80258.091.22）。在研究开始前，所有受试者均获得书面知情同意。从这项研究中获得的任何参与者受益，例如对疾病机制的新见解或可能的新疗法，将传播给研究参与者、患者群体和公众。
NCT05746221。
