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

基本信息

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
项目类别：
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&apos 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

项目摘要

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是相关的 AD 发病率较低。我们假设增加社交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，我们开发了一种由训练有素的访谈员通过以下方式提供基于对话的社交互动认知刺激协议个人电脑、网络摄像头和用户友好的交互式互联网界面。每日30分钟面对面干预组在为期 6 周的试验期内进行了沟通，而对照组则进行了为期 6 周的试验每周收到社区老年人（平均年龄 80 岁）的电话联系。这个可行性研究表明，患有以下疾病的人在基于语言的执行功能方面具有很高的依从性和有效性正常认知。基于这些积极的结果，当前的研究提出了 IIA 期试验以推进这种干预。我们建议针对 80 岁及以上认知正常且认知能力有限的人群社交互动的机会 - 轻度认知障碍 (MCI) 发病风险较高的群体。瞄准 1，我们将使用 ADNI 中先前使用的经过验证的认知复合结果来检查试验效果执行（ADNI-EF，主要结果）和记忆（ADNI-MEM，次要）功能领域的数据。心理健康和特定于个人的社交互动水平（即，在社交场合之外的平均对话）试验）将受到监测和控制。在目标 2 中，我们将评估与在相同认知领域中的功效目标1，但使用NIH-Toolbox认知测试电池，预计具有更高的信噪比试验前到试验后的变化并提供领域响应性的交叉验证。因为 NIH- Toolbox iPad版尚未广泛使用（2015年8月发布），这个目的是探索性的。这工具箱情景记忆评估，负责视觉和听觉处理，捕获区域预计在我们的试验中会受到刺激。目标 3 将探索增强功效的潜在机制通过使用 MRI 比较试验前和试验后选定大脑区域的变化来研究社交互动对认知的影响基于体素的形态测量。杏仁核和上颞叶之间的结构和功能连接还将使用扩散张量成像 (DTI) 和静息态功能磁共振成像 (R-fMRI) 来评估龈沟。总共有与 Meals on Wheels 合作，将在俄勒冈州波特兰和密歇根州底特律招募 144 名受试者和地区老龄化机构，提供低收入和少数民族人口的大型抽样框架少数民族。通过通信技术增加日常社交接触可以提供具有成本效益的方式家庭预防可以减缓认知能力下降并延缓 AD 的发病。目标年龄组是大多数发达国家人口增长最快的部分，面临着最高的风险患痴呆症和社会孤立，这两者都是认知能力下降的危险因素。用户友好，in- 这一人群迫切需要本文所寻求的家庭可持续预防方法。 6