Conversational Engagement as a Means to Delay Onset AD: Phase II Administrative Supplement
Conversational Engagement as a Means to Delay Onset AD: Phase II Administrative Supplement
批准号:
10058784
负责人:
HIROKO Hayama DODGE
金额:
$38.5万
依托单位国家:
美国
项目类别:
财政年份:
2016
资助国家:
美国
项目状态:
已结题
起止时间:
2016-09-15 至 2021-05-31
关键词:
AdherenceAdministrative SupplementAgeAged, 80 and overAgingAlzheimer&aposs DiseaseAmygdaloid structureAreaBrainBrain regionClinical TrialsCognitionCognitiveCommunicationCommunitiesControl GroupsDataDementiaDeveloped CountriesDevicesDiffusion Magnetic Resonance ImagingElderlyEpisodic memoryFaceFeasibility StudiesFunctional Magnetic Resonance ImagingFundingFutureHealthHome environmentImpaired cognitionIncidenceIndividualInternetInterventionInterviewerLanguageLow incomeMagnetic Resonance ImagingMeals on WheelsMeasuresMemoryMichiganMonitorNoiseOnset of illnessOregonOutcomeOutcome MeasurePersonal ComputersPersonal SatisfactionPersonsPhasePilot ProjectsPopulationPrevalencePreventionPrevention approachProtocols documentationPublic HealthRandomizedResearch Project GrantsRestRisk FactorsSamplingSignal TransductionSocial InteractionSocial NetworkSocial isolationStructureStructure of superior temporal sulcusTechnologyTelephoneTemporal SulcusTestingTrainingUnited States National Institutes of HealthValidationWell in selfage groupagedaging populationapolipoprotein E-4auditory processingbasebehavioral clinical trialcognitive functioncognitive testingcomputerizedcost effectivedigitalefficacy trialepidemiology studyethnic minority populationexecutive functiongroup interventionhigh riskimprovedintervention costmild cognitive impairmentmorphometryneuroimagingphase 1 studyprimary outcomerecruitsecondary outcomesocialtouchscreenuser-friendlyvalidation studiesvisual processingweek trial
中文摘要
流行病学研究表明,更大的社会网络和更频繁的社会互动是相关的
AD发生率较低。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
训练有素的面试官通过以下途径提供基于对话的社交认知刺激方案
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分钟的面对面交流
干预组在为期6周的试验期内进行交流,而对照组受试者
每周与社区老年人(平均年龄为80岁)进行电话联系。这种可行性
研究表明,在那些患有语言障碍的人中,基于语言的执行功能具有很高的依从性和有效性
正常的认知。在这些积极结果的基础上,目前的研究建议进行IIA阶段试验以推进
这种干预。我们建议以80岁及以上认知正常和有限的人为目标
社交机会--轻度认知障碍(MCI)的高危人群。在AIM
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有效性
数据,在执行(ADNI-EF,主要结果)和记忆(ADNI-MEM,次要)功能领域。
心理幸福感和特定人的社会互动水平(即
审判)将受到监测和控制。在目标2中,我们将在相同的认知领域评估疗效
目标1,但使用NIH-工具箱认知测试电池,预计会有更高的信噪比
对试验前和试验后的变化进行评估,并提供领域响应性的交叉验证。因为美国国立卫生研究院-
工具箱iPad版本还没有被广泛使用(2015年8月发布),这是一个探索性的目标。这个
工具箱情景记忆评估,它的任务是视觉和听觉处理,捕捉到了这些区域
预计会在我们的试验中受到刺激。目标3将探索增强的疗效的潜在机制
社会交互作用对认知的影响--通过MRI和MRI比较试验前后特定脑区的变化
基于体素的形态测量。杏仁核与上颞叶之间的结构和功能连接
脑沟还将使用弥散张量成像(DTI)和静息功能磁共振成像(R-fMRI)进行评估。总计
俄勒冈州波特兰和密歇根州底特律将招募144名受试者,与Meals on Wheels合作
和地区老龄机构,提供了低收入和少数民族人口的大样本框架
少数族裔。通过通信技术增加日常社交联系可以提供经济高效的
以家庭为基础的预防,可以减缓认知能力下降,推迟AD的发病。目标年龄段
是大多数发达国家人口增长最快的部分,面临着最高的
罹患痴呆症和社交孤立,这两者都是认知能力下降的风险因素。用户友好,在-
这里所寻求的家庭可持续预防方法在这一人群中迫切需要。
6.
英文摘要
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
期刊论文(0)
专著(0)
科研奖励(0)
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