The Assessment of Smart Phone Everyday Tasks (ASSET): A new IADL test for early AD

智能手机日常任务评估 (ASSET)：针对早期 AD 的新 IADL 测试

• 批准号: 10855814
• 负责人: Eric Leven
• 金额: $ 150万
• 依托单位: RIP ROAD, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10855814
• 关键词: Alzheimer' s Disease; Alzheimer' s disease pathology; Alzheimer' s disease related dementia; Alzheimer’s disease biomarker; Amyloid; Amyloid beta-Protein; Appointment; Award; Biological Markers; Boston; Businesses; Calendar; Caregiver Burden; Cellular Phone; Cerebrospinal Fluid; Clinic; Clinical; Clinical Trials; Cognitive; Collaborations; Communication; Computers; Data; Data Set; Dementia; Development; Devices; Early Diagnosis; Elderly; Emergency department visit; Future; Goals; Health Personnel; Health Status; Healthcare; Home; Hospitals; Impaired cognition; Impairment; Individual; Life; Measures; Medical; Monitor; Multicenter Studies; Neuropsychological Tests; Outcome Measure; Participant; Patients; Performance; Phase; Physical therapy; Physicians; Positron-Emission Tomography; Prevention trial; Primary Care Physician; Questionnaires; Research; Schedule; Secondary Prevention; Site; Source; Symptoms; System; Technology; Technology Transfer; Telephone; Testing; Time; United States Food and Drug Administration; Visit; Voice; Woman; amnestic mild cognitive impairment; cognitive change; cognitive performance; cognitive testing; daily functioning; design; digital; experience; functional decline; health assessment; improved; instrument; instrumental activity of daily living; mild cognitive impairment; novel; patient portal; payment; performance site; pre-clinical; prodromal Alzheimer' s disease; recruit; remote administration; remote assessment; response; smartphone application; telephone based; young adult

Project Summary Impairment in instrumental activities of daily living (IADL) is a hallmark of Alzheimer’s disease (AD) dementia and a major source of patient and caregiver burden. Similarly to cognitive changes in AD, subtle difficulties in IADL may begin even before the stage of amnestic mild cognitive impairment (MCI). Recently, greater emphasis has been placed on preclinical AD, which consists of individuals with minimal or no symptoms but biological marker evidence of AD pathology. As secondary prevention trials in preclinical AD are underway and the Food and Drug Administration (FDA) is providing new guidance for early-stage AD clinical trial outcome measures, it is imperative that we develop new ecologically valid instruments to be able to track the emergence of subtle yet clinically meaningful alterations in IADL. Older individuals are increasingly required to interact via the telephone, computer, and most recently smartphone, to perform essential IADL, such as refilling prescriptions, communicating with healthcare providers, and performing financial transactions. Most IADL tests do not use everyday technology and are insufficiently validated. The goal of this project is to complete the development of, optimize, and validate a novel performance-based IADL instrument that uses a smartphone to assess healthcare-related daily activities, the Assessment of Smartphone Everyday Tasks (ASSET). For Phase 1, during Year 1 of the award, we will first develop 5 alternate versions of ASSET. We will then recruit 20 cognitively normal young adults (YN), 20 cognitively normal older adults (CN), and 20 amnestic mild cognitive impairment (MCI) participants at a single site, the Center for Alzheimer Research and Treatment (CART) at Brigham and Women’s Hospital (BWH). Those 60 participants will undergo cognitive testing and ASSET in the research clinic. The 60 participants will then undergo short-interval (2 weeks) test-retest reliability of the 6 versions of ASSET (current version and 5 new alternate versions) remotely/at-home. For Phase 2, during Years 2 and 3 of the award, CART will serve as a coordinating center for 10 Alzheimer’s Disease Research Center (ADRC) sites, each of which will recruit 20 CN, 20 older adults with subjective cognitive decline, and 10 MCI participants for a total of 500 participants. Those participants will undergo the Uniform Data Set (UDS) neuropsychological testing battery as part of their ADRC annual visits, as well as the smartphone app tasks, ASSET, and a subjective questionnaire at baseline and 1 year later, and in between remotely at home, they will also perform ASSET on a monthly basis. Finally, AD pathology biomarker data (amyloid positron emission tomography or cerebrospinal fluid abeta positive/negative) available from other studies at the ADRC performance sites will be analyzed in about half of participants.

项目概要 日常生活工具性活动 (IADL) 受损是阿尔茨海默病 (AD) 痴呆的一个标志 与 AD 中的认知变化类似，这是患者和护理人员负担的一个主要来源。 IADL 甚至可以在遗忘性轻度认知障碍 (MCI) 阶段之前就开始，最近，人们更加重视这一点。 已被置于临床前 AD 组中，该组由具有最小症状或无症状但生物学症状的个体组成 AD 病理学的标志性证据正在进行，并且食品临床前 AD 的二级预防试验正在进行中。 美国药物管理局 (FDA) 正在为早期 AD 临床试验结果指标提供新的指导， 我们必须开发新的生态有效的工具，以便能够追踪微妙但尚未出现的现象 老年人越来越需要通过电话进行互动， 计算机和最近的智能手机，用于执行基本的 IADL，例如补充处方、 大多数 IADL 测试不使用与医疗保健提供者沟通和进行财务交易。 日常技术并没有得到充分验证该项目的目标是完成以下项目的开发： 优化并验证一种新颖的基于性能的 IADL 仪器，该仪器使用智能手机来评估 与医疗保健相关的日常活动，智能手机日常任务评估（ASSET）。 对于第一阶段，在奖励的第一年，我们将首先开发 ASSET 的 5 个替代版本。 招募 20 名认知正常的年轻人 (YN)、20 名认知正常的老年人 (CN) 和 20 名遗忘症轻度患者 阿尔茨海默病研究与治疗中心的认知障碍 (MCI) 参与者 (CART) 在布莱根妇女医院 (BWH) 这 60 名参与者将接受认知测试和 然后，60 名参与者将在研究诊所进行资产测试。 远程/在家 6 个版本的 ASSET（当前版本和 5 个新的替代版本）的可靠性。 在第二阶段，即该奖项的第 2 年和第 3 年，CART 将作为 10 名阿尔茨海默病患者的协调中心 疾病研究中心（ADRC）站点，每个站点将招募20名CN、20名具有主观认知能力的老年人 下降，总共 500 名参与者中的 10 名 MCI 参与者将接受统一数据。 将 (UDS) 神经心理学测试电池以及智能手机应用程序设置为 ADRC 年度访问的一部分 基线和一年后的任务、资产和主观问卷，以及在家远程进行的问卷调查， 他们还将每月执行 ASSET 最后，AD 病理生物标志物数据（淀粉样蛋白正电子）。 发射断层扫描或脑脊液 abeta 阳性/阴性）可从 ADRC 的其他研究中获得 性能网站大约有一半会被分析。

项目成果

Using a digital tool to detect early changes in everyday functioning in older adults: A pilot study of the Assessment of Smartphone Everyday Tasks (ASSET).

使用数字工具检测老年人日常功能的早期变化：智能手机日常任务评估 (ASSET) 的试点研究。

• 发表时间: 2023
• 作者: Dubbelman, Mark A;Hall, Tia C;Levesque, Isabella M;Mimmack, Kayden J;Sikkes, Sietske A M;Fischer, Shira H;Rentz, Dorene M;Sperling, Reisa A;Papp, Kathryn V;Amariglio, Rebecca E;Marshall, Gad A
• 通讯作者: Marshall, Gad A