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: 10645111
• 负责人: Laura D. Baker
• 金额: $ 58.22万
• 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 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10645111
• 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; Diabetes prevention; Diet; Disease; Education; Elderly; Event; Exercise; Family history of; Fingers; Genetic Risk; Genotype; Geography; Group Meetings; Health; Heart Rate; Hippocampus; Home; Hypoxemia; Impaired cognition; Impairment; Intervention; Intervention Studies; Intervention Trial; Life Style Modification; Link; Measurement; Measures; Mediterranean Diet; Memory impairment; Outcome; Outcome Assessment; 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; Unhealthy Diet; actigraphy; adjudication; arm; brain health; cardiometabolic risk; cardiometabolism; cardiovascular disorder prevention; cardiovascular health; cardiovascular risk factor; cerebrovascular health; cognitive benefits; cognitive disability; cognitive function; cohort; evidence base; exercise program; falls; health care service utilization; improved; improvement on sleep; intervention effect; lifestyle intervention; mild cognitive impairment; modifiable risk; multi-component intervention; participant enrollment; prevent; racial diversity; sedentary lifestyle; sex; sleep abnormalities; tonometry; treatment arm; treatment as usual; wrist worn device; 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 尚未确定药物治疗以预防或治疗阿尔茨海默氏病。迄今为止，非 - 通过生活方式干预措施靶向可修改风险的药理方法提供了最多 有希望的疾病延迟证据。高度普遍和慢性心脏代谢条件在 年长的美国人在漫长的前途时期成为发展的重要聚光灯 阿尔茨海默氏症和其他痴呆症 - 用于预防。美国通过生活方式保护大脑健康的研究 降低风险的干预措施（美国指针）使用已证明的多域干预方法 成功用于心血管疾病和预防糖尿病，以及芬兰队列中的认知功能 老年人。美国指针于2018年秋季推出，以调查是否随机分配到两个 结构，强度和责任制不同的生活方式干预措施会影响2多个认知轨迹 在2000年的认知正常老年人（60 - 79岁）的年份，认知能力下降的风险增加， 阿尔茨海默氏病和其他痴呆症。辅助研究Pointer-Zzz将增加家庭目标睡眠 对700名家长试验参与者的评估，以检查生活方式修改和心血管的影响 与认知能力下降和阿尔茨海默氏病有关的睡眠障碍风险管理。在 老年人，以睡眠呼吸呼吸和睡眠破碎为标志的慢性睡眠障碍是 与海马功能受损相关，大脑β-淀粉样蛋白伯恩的较高以及增加的风险 阿尔茨海默氏病。这些和其他睡眠异常也与减少心血管有关 和脑血管健康。尽管有一些证据表明饮食，运​​动和 心脏代谢风险降低可以改善睡眠，并改善睡眠益处的认知功能 成人，这些影响尚未在一项全面的严格临床试验中得到证实 客观的睡眠措施。 Pointer-zzz提供了一个前所未有的机会来利用广泛的机会 由多站点随机对照预防试验提供的资源 认知正常但可忽视的成年人测试2年强化生活方式干预的影响 使用血氧饱和度和睡眠碎片进行睡眠呼吸呼吸。 Pointer-Zzz会 还检查睡眠变化是否预测全球和领域特异性认知功能的变化以及 其他家长试验结果。指针-ZZZ结果可能会确定改善睡眠的有效策略 可能会对预防阿尔茨海默氏病和相关痴呆症产生重要的影响。