Roach Jared C, Hara Junko, Fridman Deborah, Lovejoy Jennifer C, Jade Kathleen, Heim Laura, Romansik Rachel, Swietlikowski Adrienne, Phillips Sheree, Rapozo Molly K, Shay Maria A, Fischer Dan, Funk Cory, Dill Lauren, Brant-Zawadzki Michael, Hood Leroy, Shankle William R
Institute for Systems Biology Seattle Washington USA.
Pickup Family Neurosciences Institute Hoag Memorial Hospital Presbyterian Newport Beach California USA.
Alzheimers Dement (N Y). 2022 Jul 26;8(1):e12318. doi: 10.1002/trc2.12318. eCollection 2022.
Comprehensive treatment of Alzheimer's disease (AD) requires not only pharmacologic treatment but also management of existing medical conditions and lifestyle modifications including diet, cognitive training, and exercise. We present the design and methodology for the Coaching for Cognition in Alzheimer's (COCOA) trial. AD and other dementias result from the interplay of multiple interacting dysfunctional biological systems. Monotherapies have had limited success. More interventional studies are needed to test the effectiveness of multimodal multi-domain therapies for dementia prevention and treatment. Multimodal therapies use multiple interventions to address multiple systemic causes and potentiators of cognitive decline and functional loss; they can be personalized, as different sets of etiologies and systems responsive to therapy may be present in different individuals. COCOA is designed to test the hypothesis that coached multimodal interventions beneficially alter the trajectory of cognitive decline for individuals on the spectrum of AD and related dementias (ADRD). COCOA is a two-arm prospective randomized controlled trial (RCT). COCOA collects psychometric, clinical, lifestyle, genomic, proteomic, metabolomic, and microbiome data at multiple timepoints across 2 years for each participant. These data enable systems biology analyses. One arm receives standard of care and generic healthy aging recommendations. The other arm receives standard of care and personalized data-driven remote coaching. The primary outcome measure is the Memory Performance Index (MPI), a measure of cognition. The MPI is a summary statistic of the MCI Screen (MCIS). Secondary outcome measures include the Functional Assessment Staging Test (FAST), a measure of function. COCOA began enrollment in January 2018. We hypothesize that multimodal interventions will ameliorate cognitive decline and that data-driven health coaching will increase compliance, assist in personalizing multimodal interventions, and improve outcomes for patients, particularly for those in the early stages of the AD spectrum.
The Coaching for Cognition in Alzheimer's (COCOA) trial tests personalized multimodal lifestyle interventions for Alzheimer's disease and related dementias.Dense longitudinal molecular data will be useful for future studies.Increased use of Hill's criteria in analyses may advance knowledge generation.Remote coaching may be an effective intervention.Because lifestyle interventions are inexpensive, they may be particularly valuable in reducing global socioeconomic disparities in dementia care.
阿尔茨海默病（AD）的综合治疗不仅需要药物治疗，还需要对现有医疗状况进行管理以及进行生活方式的改变，包括饮食、认知训练和运动。我们介绍了阿尔茨海默病认知指导（COCOA）试验的设计和方法。AD和其他痴呆症是由多个相互作用的功能失调生物系统相互作用导致的。单一疗法的成效有限。需要更多的干预性研究来测试多模式多领域疗法对痴呆症预防和治疗的有效性。多模式疗法使用多种干预措施来解决认知衰退和功能丧失的多种系统性原因及增强因素；它们可以是个性化的，因为不同个体可能存在不同的病因组合和对治疗有反应的系统。COCOA旨在检验这样一个假设，即针对AD和相关痴呆症（ADRD）谱系中的个体，经指导的多模式干预会有益地改变认知衰退的轨迹。COCOA是一项双臂前瞻性随机对照试验（RCT）。COCOA在2年的多个时间点为每位参与者收集心理测量、临床、生活方式、基因组、蛋白质组、代谢组和微生物组数据。这些数据有助于进行系统生物学分析。一组接受标准治疗和一般的健康老龄化建议。另一组接受标准治疗和个性化的数据驱动远程指导。主要结局指标是记忆表现指数（MPI），这是一种认知测量指标。MPI是轻度认知障碍筛查（MCIS）的汇总统计量。次要结局指标包括功能评估分期测试（FAST），这是一种功能测量指标。COCOA于2018年1月开始招募受试者。我们假设多模式干预将改善认知衰退，并且数据驱动的健康指导将提高依从性，协助多模式干预的个性化，并改善患者的结局，特别是AD谱系早期患者的结局。
阿尔茨海默病认知指导（COCOA）试验测试针对阿尔茨海默病和相关痴呆症的个性化多模式生活方式干预。密集的纵向分子数据将对未来研究有用。在分析中更多地使用希尔标准可能会推动知识生成。远程指导可能是一种有效的干预措施。由于生活方式干预成本低廉，它们在减少痴呆症护理方面的全球社会经济差距方面可能特别有价值。
