The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design.
The Coaching for Cognition in Alzheimer's (COCOA) trial: Study design.
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DOI：
10.1002/trc2.12318
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发表时间：
2022
影响因子：
4.8
通讯作者：
Shankle, William R
中科院分区：
文献类型：
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作者：
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
阿尔茨海默病（AD）的综合治疗不仅需要药物治疗，还需要管理现有的医疗条件和生活方式的改变，包括饮食，认知训练和运动。我们提出了阿尔茨海默氏症认知训练（可可）试验的设计和方法。AD和其他痴呆症是由多种相互作用的功能失调的生物系统的相互作用引起的。单一疗法的成功有限。需要更多的干预性研究来测试多模式多领域治疗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下降和功能丧失的多种全身性原因和增强剂;它们可以个性化，因为不同的个体可能存在不同的病因和对治疗有反应的系统。可可是设计来测试的假设，教练多模式干预有益地改变了AD和相关痴呆症（ADRD）的个人的认知下降的轨迹。可可是一项两组前瞻性随机对照试验（RCT）。可可COCOA在2年内的多个时间点收集每位参与者的心理测量、临床、生活方式、基因组、蛋白质组、代谢组和微生物组数据。这些数据使系统生物学分析成为可能。一只手臂接受标准护理和一般健康老龄化建议。另一只手臂接受标准护理和个性化的数据驱动远程指导。主要结果指标是记忆性能指数（MPI），一种认知指标。MPI是MCI筛选（MCIS）的汇总统计量。次要结局指标包括功能评估分期试验（FAST），一种功能指标。可可于2018年1月开始入组。我们假设，多模式干预将改善认知功能下降，数据驱动的健康指导将提高依从性，有助于个性化多模式干预，并改善患者的结局，特别是那些处于早期阶段的AD谱。阿尔茨海默氏症认知指导（可可）试验测试阿尔茨海默氏症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有助于未来的研究。在分析中更多地使用希尔标准可能会促进知识的产生。远程辅导可能是一种有效的干预措施。由于生活方式干预是廉价的，他们可能是特别有价值的，在减少全球社会经济差距的痴呆症护理。
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.