Capturing Measures That Matter: The Potential Value of Digital Measures of Physical Behavior for Alzheimer's Disease Drug Development.
Capturing Measures That Matter: The Potential Value of Digital Measures of Physical Behavior for Alzheimer's Disease Drug Development.
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DOI：
10.3233/jad-230152
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发表时间：
2023
影响因子：
4
通讯作者：
Clay, Ieuan
中科院分区：
文献类型：
--
作者：
Bachman, Shelby L.;Blankenship, Jennifer M.;Busa, Michael;Serviente, Corinna;Lyden, Kate;Clay, Ieuan
关键词：
阿尔茨海默病（Alzheimer's disease，AD）是一种严重的神经退行性疾病，是世界范围内痴呆的主要病因。尽管AD对患者、护理人员和社会的影响很大，但几乎所有的AD临床试验都失败了。这种高失败率的潜在原因是，已建立的临床结局评估未能捕捉到细微的临床变化，给患者及其护理人员带来了沉重的负担，并且未能有效地解决患者及其护理人员认为重要的健康问题。AD进展与身体行为的广泛变化相关，这些变化会影响独立运作的能力，这对于AD患者的健康来说是一个有意义的方面，并且对于诊断很重要。然而，在AD临床试验中，功能独立性的既定评估仍然没有得到充分利用，并且受到主观偏见和天花板效应的限制。使用数字健康技术被动、连续和远程评估真实世界身体行为的数字测量有可能解决其中一些局限性，并捕获AD患者的功能独立性方面。特别是，用可穿戴传感器捕获的真实世界步态，身体活动和生活空间移动性的测量可能会提供价值。需要进一步的研究来了解这些措施在AD临床研究中的有效性、可行性和可接受性。
Alzheimer’s disease (AD) is a devastating neurodegenerative disease and the primary cause of dementia worldwide. Despite the magnitude of AD’s impact on patients, caregivers, and society, nearly all AD clinical trials fail. A potential contributor to this high rate of failure is that established clinical outcome assessments fail to capture subtle clinical changes, entail high burden for patients and their caregivers, and ineffectively address the aspects of health deemed important by patients and their caregivers. AD progression is associated with widespread changes in physical behavior that have impacts on the ability to function independently, which is a meaningful aspect of health for patients with AD and important for diagnosis. However, established assessments of functional independence remain underutilized in AD clinical trials and are limited by subjective biases and ceiling effects. Digital measures of real-world physical behavior assessed passively, continuously, and remotely using digital health technologies have the potential to address some of these limitations and to capture aspects of functional independence in patients with AD. In particular, measures of real-world gait, physical activity, and life-space mobility captured with wearable sensors may offer value. Additional research is needed to understand the validity, feasibility, and acceptability of these measures in AD clinical research.
影响因子：
3.7
作者：
Rackoll T;Neumann K;Passmann S;Grittner U;Külzow N;Ladenbauer J;Flöel A
通讯作者：
Flöel A