Aging, Cognition, and Hearing Evaluation in Elders (ACHIEVE) Randomized Trial

降低与年龄相关的认知能力下降和阿尔茨海默病及相关疾病风险的新方法 鉴于人口老龄化，迫切需要老年痴呆症（ADRD）。流行病学研究 表明老年人的外周听力损失与以下因素密切相关， 加速认知能力下降和痴呆症这背后的假设机制途径 观察到的相关性包括听力差和周围声音编码失真对听力的影响。 认知负荷、大脑结构/功能和/或社交参与减少。重要的是，这些途径可能 通过使用听力技术进行全面的听力损失治疗， （助听器、其他综合助听器）和康复训练。ACHIEVE试验将 招募70-84岁认知正常的听力损失老年人，将他们以1：1的比例随机分配至 听力干预（听力需求评估、助听器安装、教育/咨询）或控制 干预（与健康教育工作者进行个性化的成功老龄化教育课程，涵盖健康老龄化 主题）。本试验将有90%的把握度检测认知变化差异的净效应量为0.26 在3年随访时，听力干预与成功的老龄化干预之间的差异（相当于35%） 认知能力下降的年速率减缓）。ACHIEVE试验的目的如下：目的1确定 ‐‐ 听力康复干预与成功的衰老控制干预对 70 ~ 84岁听力正常老年人的认知功能下降（主要结局指标） 损失目的2确定听力康复干预与成功的老龄对照的效果 对判定的痴呆事件、身体和社会次要结局指标的干预 功能，健康相关的生活质量和身体活动。ACHIEVE试验于1月开始招募 2018年，并于2019年7月17日达到850的目标N。这份行政补充申请， ACHIEVE随机试验是为了支持ACHIEVE研究的样本量从 初始目标N = 850，可能高达N ~ 1000。延长征聘与最近的 2019年6月27日召开的ACHIEVE DSMB的讨论，并“支持考虑 适度延长计划入组期，以提供额外的研究设计稳健性， 可能违反功效计算中使用的假设”。

Novel approaches to reduce the risk of age-related cognitive decline and Alzheimer's disease and related dementias (ADRD) in older adults are urgently needed given the aging of the population. Epidemiologic studies demonstrate that peripheral hearing loss in older adults is strongly and independently associated with accelerated cognitive decline and incident dementia. Hypothesized mechanistic pathways underlying this observed association include the effects of poor hearing and distorted peripheral encoding of sound on cognitive load, brain structure/function, and/or reduced social engagement. Importantly, these pathways may be modifiable with comprehensive hearing loss treatment consisting of the use of hearing technologies (hearing aids, other integrated hearing assistive devices) and rehabilitative training. The ACHIEVE trial will recruit 70-84 year-old cognitively-normal older adults with hearing loss who will be randomized 1:1 to the hearing intervention (hearing needs assessment, fitting of hearing devices, education/counseling) or control intervention (individualized successful aging education sessions with a health educator covering healthy aging topics). This trial will have 90% power to detect a net effect size of 0.26 for the difference in cognitive change between the hearing intervention vs successful aging intervention at 3 years follow-up (corresponding to a 35% slowing in the annual rate of cognitive decline). The ACHIEVE trial has the following aims: Aim 1 To determine ‐‐ the effect of hearing rehabilitative intervention versus a successful aging control intervention on rates of cognitive decline (primary outcome measure) in 70 84 year old cognitively-normal older adults with hearing loss. Aim 2 To determine the effect of hearing rehabilitative intervention versus a successful aging control intervention on secondary outcome measures of adjudicated incident dementia, physical and social functioning, health-related quality of life, and physical activity. The ACHIEVE trial began recruitment in January 2018 and reached the target N of 850 on July 17, 2019. This application for an administrative supplement to the ACHIEVE randomized trial is to support an increase in the sample size of the ACHIEVE study from the original target of N = 850 up to potentially N ~ 1000. An extension in recruitment is consistent with recent discussions from the ACHIEVE DSMB which convened on June 27, 2019 and “supports consideration of a modest extension of the planned enrollment period to provide additional robustness of the study design to possible violations in the assumptions used in the power calculations”.