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Preventing Cognitive Decline in African Americans with Mild Cognitive Impairment.

预防患有轻度认知障碍的非裔美国人的认知衰退。

基本信息

批准号：
8724314
负责人：
BARRY W. ROVNER
金额：
$ 48.47万
依托单位：
THOMAS JEFFERSON UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-30 至 2016-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8724314
关键词：
Activities of Daily Living Affect African American Aging Alzheimer&apos s Disease Attention Behavior Behavior Therapy Belief Clinical Clinical Research Clinical Trials Cognition Cognitive Communication Communities Data Dementia Diabetes Mellitus Discrimination Economics Education Elderly Epidemiology Episodic memory Genetic Goals Health Services Accessibility Home environment Housing Hypertension Impaired cognition Impairment Incidence Intervention Language Leisure Activities Life Style Literature Measures Mediating Medical Medical Genetics Mental Depression Minority Moods Nurses Occupational Outcome Outcome Study Pattern Persons Pharmaceutical Preparations Placebos Population Process Public Health Quality of life Randomized Randomized Clinical Trials Randomized Controlled Trials Recruitment Activity Research Resources Risk Factors Sampling Site Societies Socioeconomic Factors Supportive care Symptoms Testing Translating United States Verbal Learning Work base cognitive change cognitive function community setting coping cost depressive symptoms efficacy testing high risk impression innovation instrumental activity of daily living mild cognitive impairment neuropsychiatry neuropsychological normal aging prevent primary outcome programs secondary outcome social treatment effect

项目摘要

Mild Cognitive Impairment (MCI) is a transition state between normal aging and dementia that affects about 25% of older African Americans (AAs) and predicts progression to Alzheimer's disease (AD). AAs may be at higher risk for MCI and AD than Whites, possibly because of differences in genetic, medical, and socioeconomic factors. Thus, there is a pressing need to develop preventative interventions in this high risk population. Based on an extensive epidemiologic literature that suggests that cognitive, physical, and/or social activities may prevent cognitive decline, we propose to conduct a randomized clinical trial to test the efficacy of a culturally relevant intervention, Behavior Activation (BA), to prevent cognitive decline. The intervention incorporates AAs' unique beliefs, practices, and communication patterns; resonates with their coping strategies; and facilitates access to care. We are targeting AAs with the amnestic multiple domain subtype of MCI (aMCI-MD) because they are at especially high risk. A bachelor's level nurse will deliver 6 initial in-home BA treatment sessions over 2-3 months and then 6 subsequent in-home booster sessions using language, materials, and concepts that are culturally relevant to older AAs during this 24 month clinical trial. A bachelor's level nurse will similarly deliver in-home Supportive Therapy (ST) at the same treatment intensity. ST is a placebo treatment that controls for attention. We plan to recruit subjects from multiple community sites (e.g., senior centers, senior high rise apartment houses) that predominately serve older AAs and will randomize 200 older AAs with aMCI-MD to BA or ST. The primary outcome is episodic memory as measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at baseline and at months 3, 6, 12, 18, and 24. We hypothesize that 20% of BA-treated subjects, compared to 40% of ST-treated subjects, will decline by e 6 points on the HVLT-R over 24-months. A 6-point decline on the HVLT-R translates clinically to the loss of ability to perform an instrumental activity of daily living task. The secondary outcomes are general and domain-specific neuropsychological function, difficulty with instrumental activities of daily living, depression, neuropsychiatric symptoms, and quality-of-life. This research is innovative because it targets a high-risk minority sample; employs a community-based strategy to recruit subjects, deliver the intervention, and assess outcomes; and tests a nonpharmacologic intervention that resonates with the coping strategies of older AAs. Over the past ten years we have developed productive clinical and research programs with AAs in community settings and have the established relationships, preliminary data, and clinical trials expertise to conduct the proposed research.

轻度认知障碍(MCI)是介于正常衰老和痴呆症之间的一种过渡状态，影响大约 25%的老年非裔美国人(AAS)，并预测进展为阿尔茨海默病(AD)。AAS可能在 MCI和AD的风险比白人更高，可能是因为遗传、医学和社会经济因素。因此，迫切需要在这种高风险情况下制定预防性干预措施。人口。基于广泛的流行病学文献，该文献表明认知、身体和/或社交活动可能会预防认知能力下降，我们建议进行一项随机临床试验，以测试一种与文化相关的干预措施，行为激活(BA)，以防止认知能力下降。干预措施整合AA的独特信念、实践和沟通模式；与他们的应对方式产生共鸣战略；并为获得保健提供便利。我们的目标是遗忘型多域子类型的AA MCI(aMCI-MD)，因为他们的风险特别高。一名学士级别的护士将在家中接生6名初学者 BA治疗疗程超过2-3个月，然后使用语言进行随后的6次家庭强化疗程，在这24个月的临床试验中，与老年AA相关的材料和概念。单身汉的一级护士将以同样的治疗强度提供同样的家庭支持疗法(ST)。ST是一家控制注意力的安慰剂治疗。我们计划从多个社区站点招募受试者(例如，老年中心、高级高层公寓楼)，主要服务于老年AA，并将随机选择200 具有MCI-MD到BA或ST的较年长AA。根据霍普金斯学会的测量，主要结果是情节记忆言语学习测验-修订版(HVLT-R)在基线和3、6、12、18和24个月时。我们假设 20%的接受BA治疗的受试者，与40%的接受ST治疗的受试者相比，在HVLT-R上将下降e 6分超过24个月。HVLT-R下降6分在临床上转化为丧失执行日常生活任务的工具性活动。次要结果是一般性的和特定于领域的神经心理功能、日常生活工具活动困难、抑郁、神经精神病学症状和生活质量。这项研究具有创新性，因为它针对的是高危少数样本；采用了以社区为基础的招募受试者、提供干预和评估结果的策略；并测试非药理学的与老年AA的应对策略产生共鸣的干预措施。在过去的十年里，我们有在社区环境中与AA制定了富有成效的临床和研究计划，并建立了关系、初步数据和临床试验专业知识，以进行拟议的研究。