A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration Syndromes

项目概要/摘要 额颞叶变性 (FTLD) 综合征涵盖神经退行性疾病的范围 影响运动和认知功能，并且在病理上与阿尔茨海默氏病相关。在这个项目中， 我们将开发一个强大的多模式平台，用于远程监控运动症状、言语和认知 使用可穿戴传感器和数字化测试在 FTLD 综合征中发挥作用。我们将在以下时间验证该解决方案 通过收集 60 名 PSP 患者在 12 年间的纵向数据来研究进行性核上性麻痹 (PSP) 几个月。 PSP 是一种严重且快速进展的 FTLD 综合征，缺乏有效的治疗并导致 痴呆、残疾和死亡迅速发生。 PSP 的快速发展将使我们能够验证解决方案 在该 Direct II 期 SBIR 项目的时间表内，并促进 FTLD 综合征的未来研究。 在这个 Direct 第二阶段项目中，我们将从 2 个领先的 CurePSP 护理中心招募 60 名 PSP 参与者。 这些参与者将受到为期 12 个月的监测。传感器数据将使用 PAMSys 进行收集，PAMSys 是一款可穿戴设备 传感器是在 NIH STTR 资助金的支持下开发的。 PAMSys 已获得专利（美国专利号#8,206,325， 9,005,141 和 9,901,209），由 BioSensics 验证并商业化。数字化测试将被收集 使用 BioDigit Home，这是一种用于收集数字生物标记的统一解决方案，目前用于 多项由 NIH 资助的研究和制药公司赞助的神经系统疾病临床试验。生物传感有 已经定制了 BioDigit Home 解决方案来监控 PSP 中的运动、语音和认知功能，并已 对 7 名 PSP 患者进行了一项试点研究，使用开发的系统对这些患者进行了长达 3 个月的监测。 我们将从 60 名 PSP 患者收集数据，旨在开发一套用于监测运动、言语的算法 和认知功能，将能够客观评估 PSP 疾病的严重程度和进展，从而 为 PSP 创建多模式远程监控解决方案。这些工具将加速临床试验 专注于开发新型 tau蛋白病疗法（即 FTD、PSP CBS），并且可以很容易地 适应许多神经退行性疾病，包括帕金森病、多系统萎缩、 肌萎缩侧索硬化症、强直性肌营养不良和中风。 BioSensics 荣获 2020 年 Tibbetts 奖，在快速转型应用方面拥有良好的记录 将政府研究经费转化为真正的商业成果。我们技术的最初市场是 药物临床试验，BioSensics 是医疗级可穿戴传感器记录供应商 为多家制药公司提供数字化临床试验技术。当前项目将显着 扩大 BioSensics 向制药公司提供的产品，特别是提供数字化解决方案 与许多疾病相关的言语、运动和认知功能的评估。这个广告 潜力完全符合 FDA、NSF 和 NIH 关于数字化临床试验的最新建议。

Project Summary/Abstract Frontotemporal lobar degeneration (FTLD) syndromes span the spectrum of neurodegenerative disorders affecting movement and cognitive function and are pathologically related to Alzheimer's disease. In this project, we will develop a robust multi-modal platform for remote monitoring of motor symptoms, speech and cognitive function in FTLD syndromes using wearable sensors and digitized tests. We will validate this solution in Progressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP patients over a period of 12 months. PSP is a severe and rapidly progressive FTLD syndrome that lacks effective treatment and leads to rapid onset of dementia, disability and death. The rapid progression of PSP will allow us to validate the solution within the timeline of this Direct Phase II SBIR project and facilitate future studies in FTLD syndromes. In this Direct Phase II project, we will recruit 60 participants with PSP from 2 leading CurePSP Centers of Care. These participants will be monitored for 12 months. The sensor data will be collected using PAMSys, a wearable sensor developed by the support from a NIH STTR grant award. PAMSys is patented (U.S. Patents # 8,206,325, 9,005,141, and 9,901,209), validated and commercialized by BioSensics. The digitized tests will be collected using BioDigit Home, a unified solution for the collection of digital biomarkers that is currently being used in several NIH-funded studies and pharma-sponsored clinical trials in neurological disorders. BioSensics has already customized its BioDigit Home solution to monitor motor, speech and cognitive functions in PSP, and has carried out a pilot study with 7 PSP patients, who were monitored for up to 3 months using the developed system. We will collect data from 60 PSP patients in this aim to develop a set of algorithms for monitoring motor, speech and cognitive function that will enable objective assessment of PSP disease severity and progression, thereby creating a multi-modal remote monitoring solution for PSP. These tools will accelerate clinical trials that are focused on the development of novel therapeutics for tauopathies (i.e., FTD, PSP CBS) and can be readily adapted to many neurodegenerative diseases, including Parkinson's disease, multiple system atrophy, amyotrophic lateral sclerosis, myotonic dystrophy and stroke. BioSensics is a 2020 Tibbetts Award winner with a proven track record of rapidly transitioning applied governmental research funding into real commercial results. The initial market for our technology is pharmaceutical clinical trials, where BioSensics is a vendor of record of medical-grade wearable sensors and digital clinical trial technologies for multiple pharmaceutical companies. The current project will significantly broaden BioSensics' offerings to pharmaceutical companies, specifically by providing a solution for digital assessments of speech, motor and cognition function, which are relevant to many diseases. This commercial potential is fully aligned with the latest recommendations from the FDA, NSF and NIH to digitize clinical trials.