A Multi-Modal Wearable Sensor for Early Detection of Cognitive Decline and Remote Monitoring of Cognitive-Motor Decline Over Time

摘要 最近人口结构的变化导致了所谓的“痴呆症流行”的出现。痴呆症 对医疗、社会和非正式护理造成巨大压力，目前约有5500万人受到影响 世界各地的人。预计到2030年，这一数字将增加到7560万，到2050年将增加到1.355亿。 阿尔茨海默病(AD)是一种退行性大脑疾病，也是痴呆症最常见的形式。在.期间 在过去的15年里，已经进行了400多项不同的AD临床试验来管理AD症状， 综合失败率为99.6%。缺乏强大的工具来衡量和监测认知能力和 功能被认为是导致非常高的故障率的关键因素。此外，认知障碍的早期诊断 早期干预和测量其随时间的微妙进展可以防止进一步的认知 和功能衰退。最后，对于那些有以下问题的人来说，使用传统的认知筛查工具往往是有限的 高度的社会经济贫困和生活在偏远地区的个人。因此，迫切需要一种强有力的 在认知衰退的最早阶段识别个体并测量数字生物标记物的解决方案 与认知运动性能随时间的微妙变化有关。 在这项快速跟踪SBIR研究中，我们提出了开发PAMSys+，一种用于远程的多模式可穿戴传感器 基于测量双任务(DT)体力活动(例如，边走边走)的认知运动衰退监测 说话)和日常生活活动中的数字语音生物标志物。PAMSys+包括1)双向 具有同步音频信号数据采集的麦克风(位于胸腔内和胸外)， 以及2)用于收集胸部运动数据的加速计。它结合了音频和运动监控功能 使用专利方法创建首创的可穿戴传感器，用于远程监控DT的身体活动 由我们的团队开发(美国专利申请编号17/807,104)。PAMSys+还分析音频信号以进行测量 被证明与认知功能相关的数字语音生物标记物(例如，语音持续时间和速率)。 在第一阶段，我们将开发PAMSys+的原型，并在50名老年人(AGE)中演示其概念验证 60人以上)包括有认知障碍和无认知障碍的个人(每组25人)。此外，我们将评估 通过调查参与者和使用该技术的重点专家小组(n=10)对PAMSys+的可接受性 接受模型()。在第二阶段，我们将完成PAMSys+的开发，并研究其有效性 通过招募100名成年人，早期发现AD，并远程监测随着时间的推移认知运动能力下降 (60岁以上)，包括50名患有遗忘性轻度认知障碍(AMCI)或轻至中度AD的人，以及 50名年龄匹配的认知完好个体。BioSensics是2020年Tibbetts奖获得者，拥有经过验证的曲目 将政府应用研究资金迅速转化为真正的商业成果的记录。建议数 该项目与BioSensics的长期目标非常一致，是我们更广泛的 开发新技术以改善老年人生活的计划。

ABSTRACT Recent demographic changes have led to the emergence of the so-called “dementia epidemic”. Dementia causes great stress to medical, social, and informal care and is currently affecting approximately 55 million persons worldwide. This number is projected to increase to 75.6 million by 2030 and 135.5 million by 2050. Alzheimer’s disease (AD) is a degenerative brain disease and the most common form of dementia. During the last 15 years, more than 400 different AD clinical trials have been conducted for managing AD symptoms, with a combined failure rate of 99.6%. A lack of robust tools for measurement and monitoring of cognitive ability and function is considered a key contributor to the very high failure rate. Additionally, early diagnosis of cognitive decline and measuring its subtle progression over time enables early intervention to prevent further cognitive and functional decline. Finally, access to conventional cognitive screening tools is often limited for those with high socioeconomic deprivation and individuals living in remote areas. Thus, there is an urgent need for a robust solution to identify individuals in the earliest stages of cognitive decline and measure digital biomarkers associated with subtle changes in cognitive-motor performance over time. In this Fast-Track SBIR study, we propose to develop PAMSys+, a multi-modal wearable sensor for remote monitoring of cognitive-motor decline based on measuring dual-task (DT) physical activities (e.g., walking while talking) and digital speech biomarkers during activities of daily living. PAMSys+ includes 1) bi-directional microphones (located inwards to and outward from the chest) with synchronized audio signal data collection, and 2) an accelerometer to collect chest motion data. It combines the capabilities of audio and motion monitoring to create a first-in-kind wearable sensor for remote monitoring of DT physical activities using a patented method developed by our team (U.S. Patent App. No. 17/807,104). PAMSys+ also analyzes audio signals to measure digital speech biomarkers that are shown to be correlated with cognitive function (e.g., speech duration and rate). In Phase I, we will develop a prototype of PAMSys+ and demonstrate its proof of concept in 50 older adults (age 60+) including individuals with and without cognitive impairments (25 per group). Additionally, we will assess the acceptability of PAMSys+ by surveying the participants and a focused expert panel (n=10) using the technology acceptance model (TAM). In Phase II, we will complete the development of PAMSys+ and will study its validity for early detection of AD and also remote monitoring of cognitive-motor decline over time by recruiting 100 adults (age 60+) including 50 individuals with amnestic mild cognitive impairment (aMCI) or mild to moderate AD and 50 age-matched cognitive intact individuals. BioSensics is a 2020 Tibbetts Award winner with a proven track record of rapidly transitioning applied governmental research funding into real commercial results. The proposed project is well aligned with the long-term objectives of BioSensics and is a critical component of our broader plans for development of novel technologies to improve the lives of older adults.