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）是正常衰老和痴呆症之间的过渡状态，约25%的老年非洲裔美国人（AAs）受到影响，并预示着阿尔茨海默病（AD）的进展。与白人相比，黑人患轻度认知障碍和AD的风险可能更高，这可能是由于遗传、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。基于大量的流行病学文献表明，认知、身体和/或社会活动可以预防认知能力下降，我们建议进行一项随机临床试验，以测试文化相关干预的有效性，行为激活（BA），以防止认知能力下降。该干预措施结合了AAs独特的信念、实践和沟通模式；与他们的应对策略产生共鸣；并促进获得医疗服务。我们的目标是患有MCI的遗忘多域亚型（aMCI-MD）的AAs，因为它们的风险特别高。在为期24个月的临床试验中，一名本科水平的护士将在2-3个月内提供6次初始在家BA治疗课程，然后在随后的6次在家强化课程中使用与老年aa文化相关的语言、材料和概念。本科水平的护士将以同样的治疗强度提供家庭支持治疗（ST）。ST是一种控制注意力的安慰剂疗法。我们计划从多个主要为老年AAs服务的社区站点（例如，老年中心，高级高层公寓）招募受试者，并将200名患有aMCI-MD的老年AAs随机分配到BA或st。主要结果是在基线和第3、6、12、18和24个月时通过霍普金斯语言学习测试-修订（HVLT-R）测量情景记忆。我们假设，在24个月内，20%接受ba治疗的受试者的HVLT-R会下降6个点，而接受st治疗的受试者的HVLT-R会下降40%。HVLT-R下降6分在临床上意味着丧失日常生活活动的能力。次要结局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，因为它针对的是高风险的少数群体样本；采用以社区为基础的策略来招募受试者，提供干预措施并评估结果；并测试了一种非药物干预，这种干预与老年AAs的应对策略产生了共鸣。在过去的十年中，我们与社区环境中的AAs一起开发了富有成效的临床和研究项目，并建立了关系，初步数据和临床试验专业知识来进行拟议的研究。

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.