POINTER-zzz: Sleep Ancillary to U.S. Study to Protect Brain Health through Lifestyle Intervention to Reduce Risk of Alzheimer's Disease

POINTER-zzz：美国研究通过睡眠辅助通过生活方式干预降低阿尔茨海默病风险来保护大脑健康

• 批准号: 10434040
• 负责人: Laura D. Baker
• 金额: $ 113.02万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-15 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10434040
• 关键词: Accountability; Adherence; Adult; Age; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; American; Ancillary Study; Blood Tests; Brain; Cardiovascular system; Characteristics; Chronic; Clinical Trials; Cognition; Cognitive; Dementia; Development; Devices; Diabetes prevention; Diet; Disease; Education; Elderly; Enrollment; Event; Family history of; Fingers; Genetic Risk; Genotype; Geography; Group Meetings; Health; Heart Rate; Hippocampus (Brain); Home; Hypoxemia; Impaired cognition; Impairment; Intervention; Intervention Studies; Intervention Trial; Life Style Modification; Link; Measurement; Measures; Mediterranean Diet; Memory impairment; Outcome; Oxygen; Oxygen saturation measurement; Parents; Participant; Pharmacological Treatment; Physical Function; Physiologic pulse; Prevention; Prevention strategy; Prevention trial; Pulse Oximetry; Quality of life; Randomized; Randomized Controlled Trials; Resources; Rest; Risk; Risk Management; Risk Reduction; Site; Sleep; Sleep Apnea Syndromes; Sleep Fragmentations; Sleep disturbances; Structure; Subgroup; Testing; Time; Unhealthy Diet; Wrist; actigraphy; adjudicate; arm; brain health; cardiometabolic risk; cardiometabolism; cardiovascular disorder prevention; cardiovascular health; cardiovascular risk factor; cerebrovascular health; cognitive benefits; cognitive disability; cognitive function; cohort; diet and exercise; evidence base; exercise program; falls; health care service utilization; improved; intervention effect; lifestyle intervention; mild cognitive impairment; modifiable risk; multi-component intervention; prevent; racial diversity; sedentary lifestyle; sex; sleep abnormalities; tonometry; treatment arm; treatment as usual; β-amyloid burden

PROJECT SUMMARY No pharmacologic treatments have been identified to prevent or treat Alzheimer’s disease. To date, non- pharmacological approaches that target modifiable risks through lifestyle interventions provide the most promising evidence for disease delay. The impact of highly prevalent and chronic cardiometabolic conditions in older Americans places an important spotlight on the long prodromal period that precedes the development of Alzheimer’s and other dementias – for prevention. The U.S. study to PrOtect brain health through lifestyle INTErvention to Reduce risk (U.S. POINTER) uses a multi-domain intervention approach that has proven successful for cardiovascular disease and diabetes prevention, and for cognitive function in a Finnish cohort of older adults. U.S. POINTER launches in Fall 2018 to investigate whether random assignment to one of two lifestyle interventions that differ in structure, intensity, and accountability influences cognitive trajectory over 2 years in 2000 cognitively normal older adults (age 60-79 yrs) who are at increased risk for cognitive decline, Alzheimer’s disease and other dementias. The ancillary study, POINTER-zzz, will add in-home objective sleep assessments for 700 parent trial participants to examine the effects of lifestyle modification and cardiovascular risk management on sleep disturbances that have been linked to cognitive decline and Alzheimer’s disease. In older adults, chronic sleep disturbances marked by sleep-disordered breathing and sleep fragmentation are associated with impaired hippocampal functioning, greater brain beta-amyloid burden, and increased risk for Alzheimer’s disease. These and other sleep abnormalities are also associated with reduced cardiovascular and cerebrovascular health. Although there is some evidence to suggest that diet, exercise, and cardiometabolic risk reduction can improve sleep and that improved sleep benefits cognitive function in older adults, these effects have not been confirmed in a large-scale rigorous clinical trial with comprehensive and objective measures of sleep. POINTER-zzz provides an unprecedented opportunity to leverage extensive resources provided by a multi-site randomized controlled prevention trial in a well-characterized cohort of cognitively normal but Alzheimer-vulnerable adults to test the effects of a 2-year intensive lifestyle intervention on sleep-disordered breathing using oximetry and on sleep fragmentation using actigraphy. POINTER-zzz will also examine whether changes in sleep predict changes in global and domain-specific cognitive function and other parent trial outcomes. POINTER-zzz results may identify an effective strategy for improving sleep that could have important consequences for the prevention of Alzheimer’s disease and related dementias.

项目概要 迄今为止，尚未发现可预防或治疗阿尔茨海默病的药物治疗方法。 通过生活方式干预来针对可改变的风险的药理学方法提供了最大的 疾病延迟的有希望的证据。 年长的美国人将重要的焦点放在了疾病发展之前的漫长前驱期。 阿尔茨海默病和其他痴呆症——美国研究通过生活方式保护大脑健康。 降低风险干预（U.S. POINTER）采用多领域干预方法，该方法已被证明 在芬兰队列中成功预防心血管疾病和糖尿病，并改善认知功能 U.S. POINTER 于 2018 年秋季启动，旨在调查是否将随机分配给两个人中的一个 结构、强度和责任不同的生活方式干预对认知轨迹的影响超过 2 2000 年认知正常的老年人（60-79 岁）认知能力下降的风险增加， 阿尔茨海默病和其他痴呆症的辅助研究 POINTER-zzz 将增加家庭客观睡眠。 对 700 名家长试验参与者进行评估，以检查生活方式改变和心血管的影响 对与认知能力下降和阿尔茨海默病有关的睡眠障碍进行风险管理。 对于老年人来说，以睡眠呼吸障碍和睡眠碎片为特征的慢性睡眠障碍是 与海马功能受损、大脑β-淀粉样蛋白负担增加以及罹患癌症的风险增加有关 这些和其他睡眠异常也与心血管疾病有关。 尽管有一些证据表明饮食、运动和脑血管健康。 降低心脏代谢风险可以改善睡眠，改善睡眠有益于老年人的认知功能 对于成年人来说，这些作用尚未在大规模、严格的临床试验中得到证实，该试验具有全面和 POINTER-zzz 提供了一个前所未有的机会来广泛利用睡眠。 由多中心随机对照预防试验提供的资源，该试验在一个特征明确的队列中进行 认知正常但患有阿尔茨海默病的成年人，测试为期 2 年的强化生活方式干预的效果 使用血氧测定法检测睡眠呼吸障碍，使用 POINTER-zzz 检测睡眠碎片。 还检查睡眠的变化是否预示着整体和特定领域认知功能的变化， 其他家长试验结果可能会确定改善睡眠的有效策略。 可能对预防阿尔茨海默病和相关痴呆症产生重要影响。