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。

• 批准号: 8040333
• 负责人: BARRY W. ROVNER
• 金额: $ 62.01万
• 依托单位: THOMAS JEFFERSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8040333
• 关键词: Preventing; Cognitive; Decline; African; Americans

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.

描述（由申请人提供）：轻度认知障碍（MCI）是正常衰老和痴呆之间的过渡状态，影响约25%的老年非裔美国人（AA），并预测进展为阿尔茨海默病（AD）。AA可能比白人患MCI和AD的风险更高，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，身体和/或社会活动可以防止认知能力下降，我们建议进行随机临床试验，以测试文化相关的干预，行为激活（BA），以防止认知能力下降的疗效。干预措施结合了AAs独特的信仰，实践和沟通模式;与他们的应对策略产生共鸣;并促进获得护理。我们将目标锁定在MCI的遗忘型多结构域亚型（aMCI-MD），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次初始家庭BA治疗，然后在24个月的临床试验期间使用与老年AA文化相关的语言，材料和概念进行6次后续家庭助推器治疗。学士学位护士将以相同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治疗。我们计划从多个社区网站招募受试者（例如，老年中心，高层公寓），主要为老年AA服务，并将200名患有aMCI-MD的老年AA随机分为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口头学习测试修订版（HVLT-R）测量的情景记忆。我们假设20%的BA治疗受试者和40%的ST治疗受试者在24个月内HVLT-R将下降6分。HVLT-R下降6分在临床上意味着失去执行日常生活任务的工具性活动的能力。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。这项研究是创新的，因为它针对的是高风险的少数民族样本;采用基于社区的策略招募受试者，提供干预措施，并评估结果;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，我们已经开发了富有成效的临床和研究计划与AA在社区环境中，并已建立的关系，初步数据和临床试验的专业知识进行拟议的研究。 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）的最强风险因素之一。鉴于AD的巨大个人和社会成本，特别是因为它影响老年人AA，证明文化相关的非药物干预预防认知下降将促进公共卫生工作，鼓励所有老年人追求积极的生活方式。MCI和AD药物治疗临床试验的负面结果放大了这一努力的影响。在我们找到更好的AD治疗方法之前，行为干预可能是在老龄化社会中保护认知的最佳希望。