Alzheimer's Supplement to Hemodialysis-based interventions to preserve cognitive function

阿尔茨海默病补充血液透析干预措施以保持认知功能

• 批准号: 10286431
• 负责人: Mara A. McAdams DeMarco
• 金额: $ 39.86万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-09 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10286431
• 关键词: Adult; Alzheimer' s Disease; Alzheimer' s disease related dementia; Cessation of life; Characteristics; Clinical; Cognition; Communities; Consensus; Country; Data; Dementia; Diagnosis; Diagnostic; Dialysis procedure; Elderly; End stage renal failure; Enrollment; Ethnic Origin; Frequencies; General Population; Hemodialysis; Hospitalization; Hour; Impairment; Intention; Intervention; Kidney Diseases; Learning; Life; Measures; Modality; Modification; Nephrology; Outcome; Participant; Patients; Pharmaceutical Preparations; Pilot Projects; Provider; Public Health; Race; Randomized; Randomized Controlled Trials; Records; Renal dialysis; Reporting; Research; Rest; Sleep; Subgroup; Testing; Time; Trail Making Test; Transplantation; Woman; base; cognitive function; cognitive training; disability; effective intervention; executive function; exercise training; experience; feasibility testing; follow-up; high risk; improved; insight; interest; lifetime risk; men; neurocognitive test; novel; preservation; prevent; primary outcome; public health relevance; secondary outcome; sex; standard of care; symposium; tv watching

ABSTRACT: RELEVANCE TO ADRD Over 640,000 US adults suffer from ESRD, >95% of whom receive hemodialysis (HD) for the rest of their life or until transplantation. Kidney disease and HD significantly impact cognitive function, especially higher-order executive function. Only 13% of HD patients have normal cognition; HD patients experience executive function impairment at a rate 3-fold higher than the general population, leading to hospitalization, disability, death and dementia. In fact, our preliminary data suggest that HD patients have a 21-25% lifetime risk of receiving a dementia diagnosis and 4-5% lifetime risk of receiving an Alzheimer's disease and related dementias (ADRD) diagnosis; they are 19-times and 7-times more likely to be diagnosed with dementia and ADRD, respectively than older adults without ESRD. Yet, only half of patients who would meet diagnostic criteria for dementia receive a diagnosis. Among HD patients, dementia and ADRD are major public health challenges. Studies of older adults suggest that the only effective interventions for preserving executive function and preventing ADRD are cognitive training (CT) and/or exercise training (ET). However, these modalities have not been tested in HD patients; even younger HD patients suffer substantial executive function impairment leading to dementia/ADRD and could benefit from the interventions. HD frequency (3 sessions a week) and duration (4-6 hours/session) makes HD patients a “captive audience” for intradialytic CT and/or ET to mitigate executive function decline and subsequent ADRD. To test the feasibility of intradialytic interventions, we conducted a pilot RCT of 20 HD patients, comparing standard of care to CT or ET; even in this pilot, we found that intradialytic CT and ET preserved executive function. As expected, executive function in patients receiving standard of care declined substantially by 3 months (difference=47.4 seconds, P=0.006); however, this decline was not seen among those receiving CT or ET. In just 3 months, CT and ET preserved executive function compared to a striking decline with standard of care. We have built upon this pilot study and are testing interventions on a wider breadth of HD patients, for longer durations, and alone versus in combination. Our ongoing RCT (98/200 participants enrolled) tests the impact of intradialytic CT, ET, and combined CT and ET on the executive function decline associated with HD. To this study we wish to add the novel endpoint of dementia/ADRD and ascertained through novel follow-up. We propose the following aims: To 1) add a novel secondary outcomes of dementia and ADRD to an existing RCT of intradialytic cognitive training (CT) and/or exercise training (ET); 2) To quantify the effects of intradialytic cognitive training (CT) and/or exercise training (ET) on dementia and ADRD among high-risk subgroups. Through this RCT, we will learn the impact of two potential non-pharmacological interventions, cognitive and exercise training, in preserving executive function during HD and the long-term outcome of dementia and ADRD.

摘要：与ADRD相关 超过64万名美国成年人患有ESRD，> 95％的人一生都接受血液透析（HD）或 直到移植。肾脏疾病和HD显着影响认知功能，尤其是高阶 执行功能。只有13％的HD患者患有正常的认知；高清患者经历执行功能 损害比一般人群高3倍，导致住院，残疾，死亡和 失智。实际上，我们的初步数据表明HD患者的终身风险为21-25％ 痴呆症诊断和4-5％的终身风险患阿尔茨海默氏病和相关痴呆症（ADRD） 诊断；它们分别被诊断出患有痴呆和ADRD的19次和7次 比没有ESRD的老年人。但是，只有一半的患者符合痴呆症的诊断标准 接受诊断。在高清患者中，痴呆症和ADRD是主要的公共卫生挑战。研究 老年人认为，维护执行功能并防止的唯一有效干预措施 ADRD是认知训练（CT）和/或运动训练（ET）。但是，这些方式还没有 在高清患者中测试；即使是年轻的高清患者也遭受了严重的执行功能障碍 痴呆症/Adrd，可以从干预措施中受益。高清频率（每周3次）和持续时间（4-6 小时/会议）使高清患者成为乳中CT和/或ET的“圈养受众”，以减轻高管 功能下降和随后的事件。为了测试同烯性干预措施的可行性，我们进行了一次 将20位HD患者的试点RCT与CT或ET进行比较；即使在这个飞行员中，我们也发现 鉴别内CT和ET保留的执行功能。不出所料，接受的患者的执行功能 护理标准大大下降了3个月（差异= 47.4秒，p = 0.006）；但是，这种下降 在接收CT或ET的人中没有看到。在短短三个月内，CT和ET保留了执行功能 与护理标准的罢工下降相比。我们已经建立在这项试点研究的基础上，正在测试 对高清患者的更广度，更长的持续时间以及单独的与组合的干预措施。我们的 正在进行的RCT（98/200名参与者）测试了llytictic CT，ET和联合CT和ET的影响 关于高清相关的执行功能下降。在这项研究中，我们希望添加新颖的终点 痴呆症/Adrd并通过新的随访确定。我们提出以下目的：至1）添加小说 痴呆症和ADRD的次要结局，用于现有的乳化内认知训练（CT）和/或 运动训练（ET）； 2）量化子宫内认知训练（CT）和/或运动训练的影响 （ET）在高风险亚组中痴呆和ADRD。通过此RCT，我们将学习两个的影响 潜在的非药理学干预措施，认知和运动培训，以保护执行功能 在高清期间以及痴呆症和Adrd的长期结局。