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会互动是相关的 AD的发病率较低。我们假设，增加社会互动可以改善和维持 认知功能在我们之前的随机对照行为临床试验中，我们开发了一种 基于对话的社交互动认知刺激协议，由经过培训的面试官通过 个人电脑、网络摄像头和用户友好的交互式互联网界面。每天30分钟面对面 在干预组中进行了为期6周的试验，而对照组则进行了为期6周的试验。 每周接受社区老年人（平均年龄80岁）的电话联系。本可行性 一项研究表明，在那些有语言障碍的人中， 正常认知。在这些积极结果的基础上，目前的研究提出了一项IIA期试验， 这次干预。我们建议针对80岁及以上的认知正常和有限的个人， 社会交往的机会-轻度认知障碍（MCI）发病率高的群体。在Aim中 1，我们将使用先前在ADNI中使用的经验证的认知复合结局来检查试验疗效。 数据，在执行（ADNI-EF，主要结果）和记忆（ADNI-MEM，次要）功能领域。 心理健康和个人特定的社交互动水平（即，平均会话以外的 试验）将受到监测和控制。在目标2中，我们将评估与目标2相同的认知领域的疗效。 目标1，但使用NIH-1000认知测试组合，预期具有更高的信噪比 试验前到试验后的变化，并提供域响应的交叉验证。因为国家卫生研究院- iPad版本尚未广泛使用（2015年8月发布），这一目标是探索性的。的 情景记忆评估，任务都视觉和听觉处理，捕捉的领域， 在我们的试验中会受到刺激目的3将探讨增强的疗效的潜在机制 通过比较使用MRI和MRI的选定大脑区域的试验前后变化， 基于体素的形态测量杏仁核与上级颞叶的结构和功能连接 还将使用扩散张量成像（DTI）和静息状态fMRI（R-fMRI）评估脑沟。共 将在俄勒冈州的波特兰和密歇根州的底特律招募144名受试者，与“送餐上门”合作 和地区老龄化机构，提供了低收入和少数族裔人群的大量抽样框架 少数群体通过通信技术增加日常社会接触可以提供一种具有成本效益的 以家庭为基础的预防，可以减缓认知能力下降和延迟AD的发作。目标年龄组 是大多数发达国家人口中增长最快的部分， 痴呆症和社交孤立，这两者都是认知能力下降的危险因素。用户友好， 在这一人群中，迫切需要采取本报告所寻求的家庭可持续预防办法。 6