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: 10081325
• 负责人: GAD ASHER MARSHALL
• 金额: $ 32.69万
• 依托单位: ADK GROUP, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10081325
• 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; Computers; Data; Data Set; Development; Devices; Early Diagnosis; Elderly; Emergency department visit; Future; Goals; Health Personnel; Healthcare; Home environment; 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; Transact; United States Food and Drug Administration; Visit; Voice; Woman; amnestic mild cognitive impairment; base; cognitive change; cognitive performance; cognitive testing; daily functioning; design; digital; experience; functional decline; improved; instrument; instrumental activity of daily living; mild cognitive impairment; novel; patient portal; payment; performance site; pre-clinical; prodromal Alzheimer' s disease; recruit; response; smartphone Application; 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 日常生活工具活动障碍(IADL)是阿尔茨海默病(AD)痴呆的一个特征 也是患者和照顾者负担的主要来源。类似于AD的认知变化，微妙的困难 IADL甚至可能在遗忘性轻度认知障碍(MCI)阶段之前就开始了。最近，更加强调 已经被置于临床前AD，这是由除了生物学上的最小症状或没有症状的个人组成的 AD病理的标志性证据。由于临床前AD的二级预防试验正在进行中，食品 药品监督管理局(FDA)正在为AD早期临床试验结果措施提供新的指导，它 当务之急是我们必须开发新的生态有效的工具来追踪微妙而又 IADL中有临床意义的改变。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，执行基本的IADL，如重新开处方， 与医疗保健提供者沟通，并执行财务交易。大多数IADL测试不使用 日常技术，并没有得到充分的验证。这个项目的目标是完成开发， 优化并验证基于性能的新型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(资产)。 对于第一阶段，在获奖的第一年，我们将首先开发5个替代版本的ASSET。到时候我们会的 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名健忘症轻度患者 认知障碍(MCI)参与者在单个地点，阿尔茨海默病研究和治疗中心 (Cart)在布里格姆妇女医院(BWH)。这60名参与者将接受认知测试和 研究诊所里的线人。然后，60名参与者将接受短时间间隔(2周)的测试 6个ASSET版本(当前版本和5个新的备用版本)远程/在家的可靠性。 对于第二阶段，在颁奖的第二年和第三年，CART将作为10名阿尔茨海默氏症患者的协调中心 疾病研究中心(ADRC)网站，其中每个网站将招募20名CN，20名具有主观认知的老年人 下降，10名MCI参与者，共500名参与者。这些参与者将接受统一的数据 将(UDS)神经心理测试套装作为ADRC年度访问的一部分，以及智能手机应用程序 任务、资产和一年后的主观调查问卷，以及在家中远程进行的调查， 他们还将按月执行资产。最后，AD病理生物标记物数据(淀粉样正电子 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 大约一半的参与者将对表演地点进行分析。