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.

项目摘要 尚未发现预防或治疗阿尔茨海默病的药物治疗。迄今为止，非- 通过生活方式干预针对可改变风险的药理学方法提供了 有希望的疾病延迟的证据。高流行率和慢性心脏代谢疾病对 老年美国人把一个重要的聚光灯放在长前驱期之前的发展， 阿尔茨海默氏症和其他痴呆症-用于预防。美国研究通过生活方式保护大脑健康 降低风险的干预（美国POINTER）采用多领域干预方法， 成功地预防心血管疾病和糖尿病，并在芬兰队列的认知功能， 老年人U.S. POINTER将于2018年秋季推出，以调查是否将随机分配到两个 在结构、强度和责任方面不同的生活方式干预对认知轨迹的影响超过2 2000名认知正常的老年人（年龄60-79岁）中认知下降风险增加的年龄， 阿尔茨海默氏症和其他痴呆症。辅助研究POINTER-zzz将增加家庭客观睡眠 对700名父母试验参与者进行评估，以检查生活方式改变和心血管疾病的影响。 睡眠障碍的风险管理，这些睡眠障碍与认知能力下降和阿尔茨海默病有关。在 老年人，以睡眠呼吸障碍和睡眠碎片为标志的慢性睡眠障碍， 与海马功能受损、大脑β-淀粉样蛋白负荷增加和 老年痴呆症这些和其他睡眠异常也与心血管疾病的减少有关。 和脑血管健康。虽然有证据表明，饮食，运动， 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。 成年人，这些影响尚未得到证实，在一个大规模的严格的临床试验，全面和 睡眠的客观测量。POINTER-zzz提供了一个前所未有的机会， 一项多中心随机对照预防试验提供的资源， 认知正常但易患阿尔茨海默病的成年人，以测试为期2年的强化生活方式干预的效果 使用血氧测定法和使用体动记录法对睡眠呼吸紊乱和睡眠片段进行研究。POINTER-zzz将 还研究了睡眠的变化是否可以预测整体和特定领域认知功能的变化， 其他母公司试验结果。POINTER-zzz结果可以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。