Conversational Engagement as a Means to Delay Onset AD: Phase II Administrative Supplement

对话参与作为延迟 AD 发作的一种手段：第二阶段行政补充

• 批准号: 10058784
• 负责人: HIROKO Hayama DODGE
• 金额: $ 38.5万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10058784
• 关键词: Adherence; Administrative Supplement; Age; Aged, 80 and over; Aging; Alzheimer' s Disease; Amygdaloid structure; Area; Brain; Brain region; Clinical Trials; Cognition; Cognitive; Communication; Communities; Control Groups; Data; Dementia; Developed Countries; Devices; Diffusion Magnetic Resonance Imaging; Elderly; Episodic memory; Face; Feasibility Studies; Functional Magnetic Resonance Imaging; Funding; Future; Health; Home environment; Impaired cognition; Incidence; Individual; Internet; Intervention; Interviewer; Language; Low income; Magnetic Resonance Imaging; Meals on Wheels; Measures; Memory; Michigan; Monitor; Noise; Onset of illness; Oregon; Outcome; Outcome Measure; Personal Computers; Personal Satisfaction; Persons; Phase; Pilot Projects; Population; Prevalence; Prevention; Prevention approach; Protocols documentation; Public Health; Randomized; Research Project Grants; Rest; Risk Factors; Sampling; Signal Transduction; Social Interaction; Social Network; Social isolation; Structure; Structure of superior temporal sulcus; Technology; Telephone; Temporal Sulcus; Testing; Training; United States National Institutes of Health; Validation; Well in self; age group; aged; aging population; apolipoprotein E-4; auditory processing; base; behavioral clinical trial; cognitive function; cognitive testing; computerized; cost effective; digital; efficacy trial; epidemiology study; ethnic minority population; executive function; group intervention; high risk; improved; intervention cost; mild cognitive impairment; morphometry; neuroimaging; phase 1 study; primary outcome; recruit; secondary outcome; social; touchscreen; user-friendly; validation studies; visual processing; week trial

Epidemiological studies show that larger social networks and more frequent social interactions are associated with lower incidence of AD. We hypothesize that increasing social interaction could improve and sustain cognitive function. In our previous randomized, controlled, behavioral clinical trial, we developed a conversation-based social interaction cognitive stimulation protocol delivered by trained interviewers through personal computers, webcams, and a user-friendly interactive Internet interface. Daily 30-minute face-to-face communications were conducted over a 6-week trial period in the intervention group, while control subjects received weekly phone contacts among community-dwelling elderly (mean age of 80 years old). This feasibility study demonstrated high adherence and efficacy in language-based executive functions among those with normal cognition. Building on these positive results, the current study proposes a Phase IIA trial to advance this intervention. We propose to target individuals aged 80 and older with normal cognition and limited opportunities for social interactions - a group at high risk for incidence Mild Cognitive Impairment (MCI). In Aim 1, we will examine the trial efficacy using validated cognitive composite outcomes previously used in the ADNI data, in the domains of executive (ADNI-EF, primary outcome) and memory (ADNI-MEM, secondary) functions. Psychological well-being and person-specific levels of social interactions (i.e., average conversation outside of the trial) will be monitored and controlled. In Aim 2, we will assess efficacy in the same cognitive domains as in Aim 1, but using the NIH-Toolbox cognitive test battery, which is expected to have higher signal-to-noise ratio of pre- to post-trial changes and to provide cross-validation of domain responsiveness. Because the NIH- Toolbox iPad version has not been used extensively (released in August of 2015), this aim is exploratory. The Toolbox episodic memory assessment, which tasks both visual and auditory processing, captures the areas expected to be stimulated in our trial. Aim 3 will explore the underlying mechanisms of efficacy of enhanced social interaction on cognition by comparing pre- to post- trial changes in selected brain regions using MRI and voxel-based morphometry. Structural and functional connectivity between amygdala and superior temporal sulcus will also be assessed using diffusion tensor imaging (DTI) and resting state fMRI (R-fMRI). A total of 144 subjects will be recruited at Portland, Oregon, and Detroit, Michigan, collaborating with Meals on Wheels and the Area Agency on Aging, providing a large sampling frame of those with low income and from ethnic minorities. Increasing daily social contact through communication technologies could offer a cost-effective home-based prevention that could slow cognitive decline and delay the onset of AD. The targeted age group is the fastest growing segment of the population in most developed countries and faces the highest risk of developing dementia and social isolation, both of which are risk factors for cognitive declines. User-friendly, in- home sustainable prevention approaches, as sought here, are urgently needed in this population. 6

流行病学研究表明，更大的社交网络和更频繁的社交互动与 AD发病率较低。我们假设增加社会互动可以改善和维持 认知功能。在我们以前的随机，受控的行为临床试验中，我们开发了一个 训练有素的访调员通过 个人计算机，网络摄像头和用户友好的交互式Internet接口。每天面对面30分钟 在干预组的6周试验期间进行了通信，而对照对象 在社区居住的老年人（平均80岁）之间每周接触电话联系。这种可行性 研究表明，在具有语言的执行功能中，有高度的依从性和功效 正常认知。基于这些积极的结果，当前的研究提出了一项IIA期试验以提高 这种干预。我们建议针对80岁及以上的人以正常认知和有限 社交互动的机会 - 一个有轻度认知障碍风险的群体（MCI）。目标 1，我们将使用先前在ADNI中使用的经过验证的认知复合结果检查试验效率 数据，在执行域（ADNI-EF，主要结果）和内存（ADNI-MEM，次要）功能中。 心理健康和社交互动的特定水平（即，在 试验将受到监控和控制。在AIM 2中，我们将评估与同一认知领域的功效 AIM 1，但使用NIH-Toolbox认知测试电池，该电池有望具有更高的信噪比 审前变化，并提供域反应性的交叉验证。因为NIH- 工具箱iPad版本尚未广泛使用（2015年8月发布），此目标是探索性的。这 工具箱情节内存评估任务视觉和听觉处理，捕获了这些区域 预计将在我们的审判中受到刺激。 AIM 3将探索增强功效的潜在机制 通过使用MRI和MRI和 基于体素的形态计。杏仁核与上时间之间的结构和功能连通性 沟也将使用扩散张量成像（DTI）和静止状态fMRI（R-FMRI）评估。总共 144名受试者将在俄勒冈州的波特兰和密歇根州的底特律招募。 以及衰老的地区机构，提供低收入和族裔的大型抽样框架 少数民族。通过沟通技术增加日常社交接触可能会提供成本效益 基于家庭的预防可能会减缓认知能力下降并延迟AD的发作。目标年龄组 是大多数发达国家的人口中增长最快的人群，面临的最高风险 发展痴呆症和社会隔离，这都是认知能力下降的风险因素。用户友好， 在这里想要的正如在这里所寻求的那样，在此人群中迫切需要进行家庭可持续预防方法。 6