OPTIMIZING COGNITIVE ASSESSMENT IN DIAN WITH SMARTPHONE-BASED BURST TESTING - Administrative Supplement

通过基于智能手机的突发测试优化 DIAN 的认知评估 - 行政补充

• 批准号: 10180147
• 负责人: Jason J Hassenstab
• 金额: $ 39.37万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10180147
• 关键词: Administrative Supplement; Affect; Age-Years; Alzheimer' s Disease; Alzheimer' s disease risk; Alzheimer’s disease biomarker; Cellular Phone; Child; Clinic; Clinical; Clinical Trials; Cognition; Cognitive; Disease; Enrollment; Environment; Face; Family; Family member; Fatigue; Frequencies; Impaired cognition; Inherited; Laboratories; Lead; Life; Measures; Moods; Observational Study; Participant; Performance; Pilot Projects; Research; Site; Stress; Testing; Travel; base; causal variant; cognitive ability; cognitive performance; cognitive testing; design; experience; improved; insight; mutation carrier; pre-clinical; research study; sleep pattern; smartphone Application

Project Summary The Ambulatory Research in Cognition (ARC) study will leverage the increasing popularity of smartphones to improve upon standard in-clinic cognitive testing, providing a robust characterization of cognition in participants enrolled in the Dominantly-Inherited Alzheimer Network (DIAN) study. One of the most important and face-valid indicators of Alzheimer’s disease (AD) is a change in cognition, but assessing cognition in-clinic has several drawbacks. First, performance is influenced by day to day fluctuations in stress, fatigue, sleep patterns, and mood. Second, the testing takes place in environments that are fundamentally different from where cognitively demanding tasks are performed in daily life. Finally, by design, cognition is typically assessed very infrequently, usually once per year or every two years (as is the case in DIAN). One solution would be to increase the frequency of in-clinic testing, but this is impractical and burdensome, especially for DIAN participants. DIAN participants come from families that have a ~50% chance of inheriting an extremely rare autosomal dominant causal mutation for AD. Carriers of these mutations become symptomatic between 30 and 50 years of age, decades earlier than the more common sporadic form of AD. Most are still working and many are primary caretakers for their young children and often for affected family members, therefore traveling to sites more frequently for assessments is extraordinarily burdensome. The ARC study will provide a solution to these difficulties by assessing cognition with an iOS and Android app installed on ~248 DIAN participants’ personal smartphones. Every three months, participants will complete extremely brief (<3 minutes each) testing sessions 4x/day over the course of one week. Tests are averaged across the week to provide a score that captures and normalizes natural variability and dramatically increases reliability. Pilot studies show that ARC assessments demonstrate extraordinary reliability, ranging from 0.86 to 0.98. Another advantage is the ability to measure variability within a day, across a week, and across the 3- month intervals of assessments. We hypothesize that ARC assessments will be more sensitive than in-clinic assessments to disease stage and AD biomarkers and that mutation carriers in DIAN will show more variability in cognitive performance than non-carriers, even in the preclinical stages of disease. If successful, the increases in sensitivity and reliability of ARC assessments will provide extraordinary statistical power to characterize cognitive decline in observational studies of AD. In addition, ARC assessments could benefit clinical trials by shortening trial duration and requiring fewer participants.

项目概要 认知流动研究 (ARC) 研究将利用智能手机的日益普及来 改进标准的临床认知测试，提供参与者认知的可靠表征 参加了显性遗传性阿尔茨海默病网络（DIAN）研究，这是最重要、最有效的研究之一。 阿尔茨海默病 (AD) 的指标是认知的变化，但在临床上评估认知有以下几个方面 首先，表现会受到压力、疲劳、睡眠模式和日常波动的影响。 其次，测试是在与认知环境根本不同的环境中进行的。 最后，根据设计，认知通常会受到非常高的评估。 很少发生，通常每年或每两年一次（如 DIAN 中的情况）。 增加临床测试的频率，但这不切实际且繁重，尤其是对于 DIAN DIAN 参与者来自有约 50% 机会继承极其稀有基因的家庭。 AD 的常染色体显性因果突变 这些突变的携带者在 30 岁到 30 岁之间出现症状。 50 岁，比更常见的散发性 AD 早几十年，大多数仍在工作，而且很多。 是年幼孩子和受影响家庭成员的主要照顾者，因此前往 更频繁地进行评估的网站是非常繁重的。 ARC 研究将通过使用 iOS 和 Android 评估认知能力来解决这些困难 应用程序安装在约 248 名 DIAN 参与者的个人智能手机上，参与者每三个月就会完成一次。 一周内每天进行 4 次极其简短的测试（每次 <3 分钟）。 整个星期提供一个分数，捕捉和标准化自然变化并显着增加 试点研究表明，ARC 评估表现出非凡的可靠性，范围为 0.86 至 0.98 的另一个优点是能够测量一天内、一周内和 3 天内的变化。 我们希望 ARC 评估比临床评估更敏感。 对疾病阶段和 AD 生物标志物的评估以及 DIAN 中的突变携带者将表现出更多的变异性 即使在疾病的临床前阶段，认知表现也优于非携带者。 ARC 评估的敏感性和可靠性的提高将为 此外，ARC 评估也可以受益于 AD 观察性研究中的认知衰退。 通过缩短试验时间和减少人员数量来进行临床试验。