McGarry Andrew, Roesler Oliver, Liscombe Jackson, Neumann Michael, Kothare Hardik, Hosamath Abhishek, Arbatti Lakshmi, Badathala Anusha, Ruhmel Stephen, Hansen Bryan J, Quall Madeline, Istas Sandrine, Wallace Arthur, Suendermann-Oeft David, Ramanarayanan Vikram, Shoulson Ira
Department of Neurology, Cooper University Healthcare at Rowan University, Camden, NJ.
Modality.AI, Inc, San Francisco, CA.
Mayo Clin Proc Digit Health. 2025 May 6;3(2):100224. doi: 10.1016/j.mcpdig.2025.100224. eCollection 2025 Jun.
Traditional clinical trials in neurodegenerative disorders have utilized combinations of examination-based outcomes, global assessments by investigators and participants, and scales aimed at function, some of which are patient-reported outcomes. It is debatable whether these tools optimally convey therapeutic efficacy. A complementary approach using digital biomarkers to surpass exam-based limitations for detecting physical change coupled with a direct report from participants on what their sources of suffering are could be a useful advance in reporting beneficial effects of interventions, particularly if changes track together. We sought to determine the feasibility of remotely assessing speech, facial features, and cognition in an mild cognitive impairment (MCI) population, whether those extracted features could distinguish MCI from controls, and to explore what self-reported problems could reveal about the MCI experience. Our web-based platform was easy to use and revealed facial features in particular as capable of discriminating MCI from controls. Using the features that showed a statistically significant difference between cohorts (<.01) produced an area under the receiver operating curve of 0.75. Self-reported problems with cognition, gait, sleep, and behavior were more common in the MCI group. The MCI was associated with 6 times more difficulty with falls (n=6 vs 1). These data support the feasibility and discriminative utility of using remote monitoring technology in combination with participant self-report in an MCI population. Future work will investigate the extent to which multimodal biomarkers combined with self-report can characterize MCI longitudinally and for potential research applications as a measure of therapeutic effect.
神经退行性疾病的传统临床试验采用了基于检查的结果、研究者和参与者的整体评估以及针对功能的量表等多种方式,其中一些是患者报告的结果。这些工具是否能最佳地传达治疗效果仍存在争议。一种补充方法是使用数字生物标志物来超越基于检查的局限性以检测身体变化,并结合参与者对其痛苦来源的直接报告,这可能是在报告干预措施的有益效果方面的一个有用进展,特别是如果变化能够同步跟踪。我们试图确定在轻度认知障碍(MCI)人群中远程评估言语、面部特征和认知的可行性,这些提取的特征是否能将MCI与对照组区分开来,并探索自我报告的问题能揭示关于MCI经历的哪些信息。我们基于网络的平台易于使用,尤其显示出面部特征能够区分MCI和对照组。使用在队列之间显示出统计学显著差异(<.01)的特征,受试者工作特征曲线下面积为0.75。MCI组在认知、步态、睡眠和行为方面的自我报告问题更为常见。MCI患者跌倒的困难程度是对照组的6倍(n = 6比1)。这些数据支持了在MCI人群中结合使用远程监测技术和参与者自我报告的可行性和鉴别效用。未来的工作将研究多模式生物标志物与自我报告相结合在多大程度上能够纵向表征MCI,并作为治疗效果的一种衡量指标用于潜在的研究应用。