BeyeOMARKER 研究的原理和设计:前瞻性评估眼科诊所早期检测阿尔茨海默病病理变化的血液和眼部生物标记物。

IF 7.9 1区 医学 Q1 CLINICAL NEUROLOGY Alzheimer's Research & Therapy Pub Date : 2024-08-21 DOI:10.1186/s13195-024-01545-1
Ilse Bader, Colin Groot, H Stevie Tan, Jean-Marie A Milongo, Jurre den Haan, Inge M W Verberk, Keir Yong, Julie Orellina, Shannon Campbell, David Wilson, Argonde C van Harten, Pauline H B Kok, Wiesje M van der Flier, Yolande A L Pijnenburg, Frederik Barkhof, Elsmarieke van de Giessen, Charlotte E Teunissen, Femke H Bouwman, Rik Ossenkoppele
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引用次数: 0

摘要

背景:阿尔茨海默病(AD)是一种常见、复杂和多因素的疾病,可能需要通过多种转诊途径进行筛查,以便及早发现并在未来实施有针对性的干预措施。血液和眼部生物标志物分别能提供有关注意力缺失症病理生理变化和视网膜表现的信息,因此有望成为低成本、可扩展且方便患者的注意力缺失症早期检测工具。眼科诊所为评估这些潜在的注意力缺失症筛查工具的性能提供了一个令人感兴趣的真实世界概念验证环境,因为眼睛和大脑之间存在着错综复杂的联系,患有眼部疾病的老龄人口中可能富含注意力缺失症病理,而且有可能为认识不足的患者群体提供加速诊断途径:BeyeOMARKER研究是一项前瞻性、观察性、纵向队列研究,旨在纳入到眼科门诊就诊的患者。纳入标准为年龄≥ 50 岁且之前未确诊过痴呆症。排除的眼部疾病包括外伤性损伤、表皮炎症以及眼睛周围结构中与视觉无关的疾病。BeyeOMARKER 队列(n = 700)将在眼科诊所进行采血,以评估血浆 p-tau217 水平和简短的认知筛查。随后将邀请所有参与者进行年度纵向随访,包括远程认知筛查和问卷调查。BeyeOMARKER + 队列(n = 150)由 100 名血浆 p-tau217 阳性参与者和 50 名从 BeyeOMARKER 队列中选出的匹配阴性对照组成,他们还将接受 Aβ-PET 和 tau-PET、核磁共振成像、视网膜成像(包括高光谱成像(主要)、宽视场成像、光学相干断层扫描(OCT)和 OCT-血管成像(次要)))以及认知和皮层视力评估:我们的目标是在 2024 年 4 月至 2027 年 3 月期间实施目前的方案。主要结果包括血浆p-tau217和高光谱视网膜成像检测AD病理的性能(以Aβ和tau-PET视觉读数为参考标准)以及检测认知功能下降的性能。最初的随访期约为 2 年,但如果获得额外资助,随访期可能会延长:我们预计,BeyeOMARKER 研究将证明在其他筛查环境中基于血液和眼部生物标志物进行早期注意力缺失症检测的可行性,并将提高我们对眼脑联系的认识:BeyeOMARKER研究(Eudamed CIV ID:CIV-NL-23-09-044086;注册日期:2024年3月19日)已获得阿姆斯特丹UMC伦理审查委员会的批准。
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Rationale and design of the BeyeOMARKER study: prospective evaluation of blood- and eye-based biomarkers for early detection of Alzheimer's disease pathology in the eye clinic.

Background: Alzheimer's disease (AD) is a common, complex and multifactorial disease that may require screening across multiple routes of referral to enable early detection and subsequent future implementation of tailored interventions. Blood- and eye-based biomarkers show promise as low-cost, scalable and patient-friendly tools for early AD detection given their ability to provide information on AD pathophysiological changes and manifestations in the retina, respectively. Eye clinics provide an intriguing real-world proof-of-concept setting to evaluate the performance of these potential AD screening tools given the intricate connections between the eye and brain, presumed enrichment for AD pathology in the aging population with eye disorders, and the potential for an accelerated diagnostic pathway for under-recognized patient groups.

Methods: The BeyeOMARKER study is a prospective, observational, longitudinal cohort study aiming to include individuals visiting an eye-clinic. Inclusion criteria entail being ≥ 50 years old and having no prior dementia diagnosis. Excluded eye-conditions include traumatic insults, superficial inflammation, and conditions in surrounding structures of the eye that are not engaged in vision. The BeyeOMARKER cohort (n = 700) will undergo blood collection to assess plasma p-tau217 levels and a brief cognitive screening at the eye clinic. All participants will subsequently be invited for annual longitudinal follow-up including remotely administered cognitive screening and questionnaires. The BeyeOMARKER + cohort (n = 150), consisting of 100 plasma p-tau217 positive participants and 50 matched negative controls selected from the BeyeOMARKER cohort, will additionally undergo Aβ-PET and tau-PET, MRI, retinal imaging including hyperspectral imaging (primary), widefield imaging, optical coherence tomography (OCT) and OCT-Angiography (secondary), and cognitive and cortical vision assessments.

Results: We aim to implement the current protocol between April 2024 until March 2027. Primary outcomes include the performance of plasma p-tau217 and hyperspectral retinal imaging to detect AD pathology (using Aβ- and tau-PET visual read as reference standard) and to detect cognitive decline. Initial follow-up is ~ 2 years but may be extended with additional funding.

Conclusions: We envision that the BeyeOMARKER study will demonstrate the feasibility of early AD detection based on blood- and eye-based biomarkers in alternative screening settings, and will improve our understanding of the eye-brain connection.

Trial registration: The BeyeOMARKER study (Eudamed CIV ID: CIV-NL-23-09-044086; registration date: 19th of March 2024) is approved by the ethical review board of the Amsterdam UMC.

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来源期刊
Alzheimer's Research & Therapy
Alzheimer's Research & Therapy 医学-神经病学
CiteScore
13.10
自引率
3.30%
发文量
172
审稿时长
>12 weeks
期刊介绍: Alzheimer's Research & Therapy is an international peer-reviewed journal that focuses on translational research into Alzheimer's disease and other neurodegenerative diseases. It publishes open-access basic research, clinical trials, drug discovery and development studies, and epidemiologic studies. The journal also includes reviews, viewpoints, commentaries, debates, and reports. All articles published in Alzheimer's Research & Therapy are included in several reputable databases such as CAS, Current contents, DOAJ, Embase, Journal Citation Reports/Science Edition, MEDLINE, PubMed, PubMed Central, Science Citation Index Expanded (Web of Science) and Scopus.
期刊最新文献
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