Preventing Cognitive Decline in African Americans with Mild Cognitive Impairment.

描述(由申请人提供)：轻度认知障碍(MCI)是一种介于正常衰老和痴呆症之间的过渡状态，影响约25%的老年非裔美国人(AAs)，并预测进展为阿尔茨海默病(AD)。与白人相比，AAS患MCI和AD的风险可能更高，可能是因为遗传、医学和社会经济因素的差异。因此，迫切需要在这一高危人群中制定预防性干预措施。基于广泛的流行病学文献，表明认知、体力和/或社会活动可以防止认知下降，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)--预防认知下降的有效性。这种干预结合了协会独特的信仰、做法和沟通模式，与他们的应对策略产生共鸣，并促进了获得护理的机会。我们的目标是MCI的遗忘多域亚型(aMCI-MD)的AA，因为它们的风险特别高。一名学士级别的护士将在2-3个月内提供6次最初的家庭BA治疗课程，然后在24个月的临床试验中使用与老年AA相关的语言、材料和概念进行6次家庭助教课程。学士级别的护士将以同样的治疗强度提供同样的家庭支持疗法(ST)。ST是一种控制注意力的安慰剂治疗。我们计划从主要为老年AA服务的多个社区站点(例如，老年中心、高级高层公寓楼)招募受试者，并将200名患有MCI-MD的老年AA随机分配到BA或ST。主要结果是情景记忆，在基线和3、6、12、18和24个月时用霍普金斯语言学习测试修订版(HVLT-R)测量。我们假设20%接受BA治疗的受试者，与40%接受ST治疗的受试者相比，在24个月的时间里，在HVLT-R上将下降6个点。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的能力。次要结果是一般和特定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；采用了基于社区的策略来招募受试者、提供干预和评估结果；并测试了与老年AA的应对策略产生共鸣的非药物干预。在过去的十年里，我们在社区环境中与AA开发了富有成效的临床和研究计划，并拥有已建立的关系、初步数据和临床试验专业知识来进行拟议的研究。 公共卫生相关性：相关性：轻度认知障碍(MCI)是美国阿尔茨海默病(AD)的最大风险因素之一。鉴于阿尔茨海默病的巨大个人和社会代价，特别是在它影响到老年人的情况下，表明具有文化相关性的非药物干预防止认知能力下降将促进公共卫生努力，鼓励所有老年人追求积极的生活方式。这一努力的影响因治疗MCI和AD的药物临床试验的负面结果而放大。在我们找到治疗阿尔茨海默病的更好方法之前，行为干预可能是在老龄化社会中保存认知的最大希望。

DESCRIPTION (provided by applicant): 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. PUBLIC HEALTH RELEVANCE: Relevance: Mild Cognitive Impairment (MCI) is one of the strongest risk factors for Alzheimer's disease (AD) in the United States. Given the enormous personal and societal costs of AD, especially as it affects older AAs, demonstrating that a culturally relevant, nonpharmacological intervention prevents cognitive decline would boost public health efforts to encourage all older persons to pursue active lifestyles. The impact of this effort is magnified by the negative results of clinical trials of drug treatments for MCI and AD. Until we find better treatments for AD, behavioral interventions may hold the best hope for preserving cognition in an aging society.