Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot

多域阿尔茨海默病风险降低研究 (MARRS) 试点

• 批准号: 10077807
• 负责人: SASCHA DUBLIN
• 金额: $ 164.79万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10077807
• 关键词: Activities of Daily Living; Address; Affect; Age; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' s disease risk; Area; Benefits and Risks; Cardiovascular Diseases; Cognition; Cognitive; Cohort Studies; Cost of Illness; Country; Data; Dementia; Diabetes Mellitus; Diet; Disease; Education; Elderly; Europe; Future; Goals; Health; Health education; Healthcare Systems; Hypertension; Impaired cognition; Incidence; Individual; Integrated Delivery of Health Care; Intervention; Intervention Studies; Life Style; Medical; Medication Management; Mental Depression; Obesity; Outcome; Participant; Patients; Performance; Pharmaceutical Preparations; Physical Performance; Pilot Projects; Population; Population Study; Preparation; Prevalence; Prevention; Prevention trial; Primary Prevention; Psyche structure; Public Health; Quality of life; Randomized; Risk Factors; Risk Management; Risk Reduction; Sample Size; Site; Sleep; Smoking; System; Technology; Testing; Work; base; behavior change; brain health; cardiovascular risk factor; cognitive change; cognitive testing; depressive symptoms; experience; feasibility testing; good diet; group intervention; health care delivery; health care settings; healthy lifestyle; high risk; high risk population; improved; innovation; interest; mild cognitive impairment; modifiable risk; motivated behavior; multi-site trial; multimodality; novel; older patient; personalized intervention; phase III trial; physical inactivity; pilot trial; population based; prevent; primary outcome; programs; secondary outcome; sleep quality; smoking cessation; social; therapy design

Alzheimer's disease prevalence is expected to triple by 2050, and current medications do not change the disease course. However, recent studies have projected that up to 30% of Alzheimer's disease may be preventable by targeting modifiable risk factors. Indeed, population-based studies are finding that, although the total number of dementia cases is growing, age-specific incidence rates are declining in parallel with population-level reductions in risk factors such as low education, smoking and cardiovascular disease. Furthermore, studies in Europe have demonstrated slower cognitive decline and less cognitive impairment with multi-domain risk reduction interventions. Given the importance of Alzheimer's prevention and the potential benefits of risk reduction for general as well as brain health, even relatively small reductions in Alzheimer's incidence would have a dramatic public health impact. Despite the tremendous promise of the multi-domain risk reduction approach, no primary prevention trials have been performed in the U.S. We propose to conduct a pilot study of a multi-domain Alzheimer's disease risk reduction intervention in the U.S. To maximize feasibility and the potential for implementation, we propose to perform our trial within an integrated healthcare delivery system. In addition, we plan to utilize a personalized intervention, which has proven successful in the healthcare setting for managing conditions such as depression and hypertension, and which should yield greatest change on risk factors. Specifically, we propose to randomize 200 higher-risk older adults (age ≥70 with subjective cognitive complaints, performance in the lower end of normal on a cognitive test and ≥ 2 modifiable risk factors that will be targeted by our intervention) to a two year Multi-domain Alzheimer's Risk Reduction Study (MARRS) intervention or a Health Education (HE) control. In the MARRS intervention group, the team will work with participants to develop a personalized action plan to address risk reduction including cardiovascular risk management; smoking cessation; physical, mental and social activity; healthy diet; improved sleep quality and medication management. The goals of our study are to collect pilot data on the effect of MARRS on 2-year rate of cognitive decline compared to HE (Aim 1); compare changes in Alzheimer's modifiable risk factors (Aim 2); and gather preliminary data on the effect of MARRS versus HE on other important health-related outcomes (Aim 3). We will also compare strategies for identifying higher-risk patients for this and future studies. This innovative pilot trial will provide critically needed information to support a future multi-site trial, with the ultimate goal of delaying or preventing cognitive decline leading to Alzheimer's disease.

到 2050 年，阿尔茨海默病的患病率预计将增加两倍，而目前的药物并不能改变这一现状 病程。然而，最近的研究预测，高达 30% 的阿尔茨海默病可能与 通过针对可改变的风险因素来预防。事实上，基于人群的研究发现，尽管 痴呆症病例总数不断增加，特定年龄发病率同时下降 人口层面减少教育程度低、吸烟和心血管疾病等危险因素。 此外，欧洲的研究表明，认知衰退速度较慢，认知障碍也较少 多领域降低风险干预措施。鉴于预防阿尔茨海默病的重要性和潜力 降低风险对一般健康和大脑健康都有好处，甚至可以相对较小地降低阿尔茨海默病的风险 的发生将对公共健康产生巨大影响。尽管多域有着巨大的前景 降低风险的方法，美国尚未进行一级预防试验。我们建议进行 在美国进行的一项多领域阿尔茨海默病风险降低干预试点研究 可行性和实施潜力，我们建议在综合医疗保健中进行试验 输送系统。此外，我们计划利用个性化干预措施，这在以下领域已被证明是成功的： 用于管理抑郁症和高血压等疾病的医疗保健环境，以及应该产生的效果 风险因素变化最大。具体来说，我们建议将 200 名高风险老年人（年龄≥70 岁）随机分组 有主观认知抱怨，认知测试中的表现处于正常值的下限且 ≥ 2 我们干预的目标是可改变的风险因素）到两年多领域阿尔茨海默病风险 减少研究 (MARRS) 干预或健康教育 (HE) 对照。在 MARRS 干预组中， 该团队将与参与者合作制定个性化的行动计划来解决风险降低问题，包括 心血管风险管理；戒烟；身体、心理和社会活动；健康饮食； 改善睡眠质量和药物管理。我们研究的目标是收集有关 与 HE 相比，MARRS 对 2 年认知能力下降率的影响（目标 1）；比较阿尔茨海默病的变化 可改变的风险因素（目标 2）；并收集 MARRS 与 HE 对其他疾病影响的初步数据 重要的健康相关成果（目标 3）。我们还将比较识别高风险患者的策略 为了这个和未来的研究。这项创新的试点试验将提供支持未来急需的信息 多中心试验，最终目标是延缓或预防导致阿尔茨海默病的认知能力下降。