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.

项目摘要 工具性日常生活活动（IADL）障碍是阿尔茨海默病（AD）痴呆的一个标志 并且是患者和护理者负担的主要来源。与AD的认知变化类似， IADL甚至可以在遗忘型轻度认知障碍（MCI）阶段之前开始。最近，更加强调 已被置于临床前AD，其中包括具有最小或无症状但生物学特征的个体。 AD病理学的标志物证据。由于临床前AD的二级预防试验正在进行中， 美国食品药品监督管理局（FDA）正在为早期AD临床试验结局指标提供新的指导， 我们必须开发新的生态有效的工具，以便能够跟踪微妙的出现， 有临床意义的IADL改变。越来越多的老年人需要通过电话进行互动， 计算机，以及最近的智能手机，以执行基本的IADL，如重新填写处方， 与医疗保健提供者通信，并执行金融交易。大多数IADL测试不使用 日常技术，并没有得到充分的验证。该项目的目标是完成开发， 优化和验证一种新的基于性能的IADL仪器，该仪器使用智能手机来评估 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。然后我们将 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名轻度遗忘者。 认知障碍（MCI）参与者在一个单一的网站，阿尔茨海默病研究和治疗中心 布里格姆妇女医院（Brigham and Women's Hospital，BWH）这60名参与者将接受认知测试， 研究诊所的资产。然后，60名参与者将接受短间隔（2周）的重测 6个版本的ASSET（当前版本和5个新的替代版本）远程/在家的可靠性。 对于第二阶段，在第二年和第三年的奖励，CART将作为一个协调中心，为10阿尔茨海默氏症 疾病研究中心（ADRC）的研究中心，每个研究中心将招募20名CN，20名患有主观认知障碍的老年人， 下降，10名MCI参与者，共计500名参与者。这些参与者将接受统一数据 设置（UDS）神经心理测试电池作为其ADRC年度访问的一部分，以及智能手机应用程序 任务，ASSET和主观问卷调查，在基线和1年后，以及在远程在家之间， 他们也会按月进行资产评估。最后，AD病理学生物标志物数据（淀粉样蛋白正电子转移）可以用于AD病理学研究。 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 将在大约一半的参与者中分析性能站点。

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).

• DOI: 10.1002/dad2.12506
• 发表时间: 2023-10
• 期刊: ALZHEIMER'S & DEMENTIA: DIAGNOSIS, ASSESSMENT & DISEASE MONITORING
• 影响因子: 5.3
• 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