Optimizing Cognitive Assessment in DIAN with Smartphone-based burst testing

通过基于智能手机的突发测试优化 DIAN 中的认知评估

• 批准号: 9768948
• 负责人: Jason J Hassenstab
• 金额: $ 73.81万
• 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/9768948
• 关键词: Affect; Age of Onset; Age-Years; Alzheimer' s Disease; Alzheimer' s disease risk; Alzheimer’s disease biomarker; Amyloid; Android; Cellular Phone; Cerebrospinal Fluid; Child; Clinic; Clinical; Clinical Trials; Cognition; Cognitive; Devices; Disease; Disease Progression; Enrollment; Environment; Episodic memory; Evaluation; Exhibits; Face; Family; Family member; Fatigue; Frequencies; Geography; Image; Impaired cognition; Inherited; Laboratories; Lead; Life; Liquid substance; Measurement; Measures; Moods; Nature; Neuropsychological Tests; Observational Study; Participant; Pathology; Performance; Pilot Projects; Positron-Emission Tomography; Research; Role; Site; Source; Stress; Symptoms; Technology; Testing; Time; Translating; Travel; Visit; attentional control; base; causal variant; cognitive ability; cognitive change; cognitive performance; cognitive testing; design; experience; improved; insight; mutation carrier; open source; pre-clinical; rate of change; research clinical testing; research study; response; sleep pattern; smartphone Application; stressor; success; tau Proteins

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.

认知研究（ARC）研究将利用智能手机的普及到 改进标准的临床内认知测试，提供参与者认知的强大表征 参与了主要持有的阿尔茨海默氏症网络（Dian）研究。最重要，最重要的valid之一 阿尔茨海默氏病（AD）的指标是认知的变化，但是评估认知临界值有几个 缺点。首先，性能受到压力，疲劳，睡眠方式的日常波动的影响 情绪。其次，测试发生在与认知上不同的环境中 在日常生活中执行苛刻的任务。最后，根据设计，认知通常非常评估 很少，通常每年一次或每两年一次（就像Dian一样）。一种解决方案是 增加了临床内测试的频率，但这是不切实际的和朴实的，尤其是对于Dian 参与者。戴安（Dian）的参与者来自有可能继承极为罕见的家庭的家庭 AD的常染色体显性因果突变。这些突变的载体在30至30之间成为症状 50岁，比更常见的零星形式的AD早几十年。大多数仍在工作，很多 是年幼孩子的主要看护者，经常是受影响的家庭成员，因此前往 更频繁的评估网站非常负担重大。 ARC研究将通过用iOS和Android评估认知来为这些困难提供解决方案 应用程序安装在〜248 Dian参与者的个人智能手机上。每三个月，参与者将完成 在一周的时间内，非常简短（每个<3分钟）测试4倍/天。测试平均 在一周中，提供一个捕获自然变异性并大大增加的分数 可靠性。试点研究表明，ARC评估表现出非凡的可靠性，范围从0.86到 0.98。另一个优点是能够在一天，一周以及整个3-的一天内测量可变性 评估的月间隔。我们假设ARC评估将比临床更敏感 评估疾病阶段和AD生物标志物以及Dian中的突变携带者将显示出更多的可变性 在认知表现方面，即使在疾病的临床前阶段，也是如此。如果成功， ARC评估的敏感性和可靠性提高将为非凡的统计能力提供 表征AD观察研究的认知能力下降。此外，ARC评估可能会受益 临床试验通过缩短试验持续时间，需要更少的参与者。