Muurling Marijn, de Boer Casper, Kozak Rouba, Religa Dorota, Koychev Ivan, Verheij Herman, Nies Vera J M, Duyndam Alexander, Sood Meemansa, Fröhlich Holger, Hannesdottir Kristin, Erdemli Gul, Lucivero Federica, Lancaster Claire, Hinds Chris, Stravopoulos Thanos G, Nikolopoulos Spiros, Kompatsiaris Ioannis, Manyakov Nikolay V, Owens Andrew P, Narayan Vaibhav A, Aarsland Dag, Visser Pieter Jelle
Alzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, the Netherlands.
Takeda Pharmaceuticals International Co., Cambridge, MA, USA.
Alzheimers Res Ther. 2021 Apr 23;13(1):89. doi: 10.1186/s13195-021-00825-4.
Functional decline in Alzheimer's disease (AD) is typically measured using single-time point subjective rating scales, which rely on direct observation or (caregiver) recall. Remote monitoring technologies (RMTs), such as smartphone applications, wearables, and home-based sensors, can change these periodic subjective assessments to more frequent, or even continuous, objective monitoring. The aim of the RADAR-AD study is to assess the accuracy and validity of RMTs in measuring functional decline in a real-world environment across preclinical-to-moderate stages of AD compared to standard clinical rating scales.
This study includes three tiers. For the main study, we will include participants (n = 220) with preclinical AD, prodromal AD, mild-to-moderate AD, and healthy controls, classified by MMSE and CDR score, from clinical sites equally distributed over 13 European countries. Participants will undergo extensive neuropsychological testing and physical examination. The RMT assessments, performed over an 8-week period, include walk tests, financial management tasks, an augmented reality game, two activity trackers, and two smartphone applications installed on the participants' phone. In the first sub-study, fixed sensors will be installed in the homes of a representative sub-sample of 40 participants. In the second sub-study, 10 participants will stay in a smart home for 1 week. The primary outcome of this study is the difference in functional domain profiles assessed using RMTs between the four study groups. The four participant groups will be compared for each RMT outcome measure separately. Each RMT outcome will be compared to a standard clinical test which measures the same functional or cognitive domain. Finally, multivariate prediction models will be developed. Data collection and privacy are important aspects of the project, which will be managed using the RADAR-base data platform running on specifically designed biomedical research computing infrastructure.
First results are expected to be disseminated in 2022.
Our study is well placed to evaluate the clinical utility of RMT assessments. Leveraging modern-day technology may deliver new and improved methods for accurately monitoring functional decline in all stages of AD. It is greatly anticipated that these methods could lead to objective and real-life functional endpoints with increased sensitivity to pharmacological agent signal detection.
阿尔茨海默病(AD)的功能衰退通常使用单时间点主观评定量表来衡量,这些量表依赖于直接观察或(照顾者的)回忆。远程监测技术(RMTs),如智能手机应用程序、可穿戴设备和家庭传感器,可以将这些定期主观评估转变为更频繁甚至连续的客观监测。RADAR-AD研究的目的是评估与标准临床评定量表相比,RMTs在临床前至中度AD阶段的真实环境中测量功能衰退的准确性和有效性。
本研究包括三个层次。对于主要研究,我们将纳入来自13个欧洲国家均匀分布的临床站点的参与者(n = 220),包括临床前AD、前驱AD、轻度至中度AD患者以及健康对照,根据MMSE和CDR评分进行分类。参与者将接受广泛的神经心理学测试和体格检查。在8周内进行的RMT评估包括步行测试、财务管理任务、增强现实游戏、两个活动追踪器以及安装在参与者手机上的两个智能手机应用程序。在第一个子研究中,将在40名参与者的代表性子样本家中安装固定传感器。在第二个子研究中,10名参与者将在智能家居中停留1周。本研究的主要结局是四个研究组之间使用RMTs评估的功能领域概况差异。将分别对四个参与者组的每个RMT结局指标进行比较。每个RMT结局将与测量相同功能或认知领域的标准临床测试进行比较。最后,将开发多变量预测模型。数据收集和隐私是该项目的重要方面,将使用运行在专门设计的生物医学研究计算基础设施上的RADAR-base数据平台进行管理。
预计2022年公布初步结果。
我们的研究非常适合评估RMT评估的临床效用。利用现代技术可能会带来新的和改进的方法,以准确监测AD各个阶段的功能衰退。人们非常期待这些方法能够带来客观的、基于现实生活的功能终点,提高对药物信号检测灵敏度。