Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot

预计到2050年，阿尔茨海默病的患病率将增加两倍，目前的药物并不能改变 病程。然而，最近的研究预测，高达30%的阿尔茨海默氏症可能是 可以通过瞄准可改变的风险因素来预防。事实上，基于人口的研究发现，尽管 痴呆症病例总数在增长，特定年龄段的发病率在下降 在人口层面减少低教育程度、吸烟和心血管疾病等危险因素。 此外，在欧洲的研究表明，使用 多领域降低风险干预措施。鉴于预防阿尔茨海默氏症的重要性和潜在的 降低风险对整体和大脑健康的好处，甚至对阿尔茨海默氏症的相对较小的降低 这种情况会对公众健康产生巨大影响。尽管多域的巨大前景 降低风险的方法，在美国还没有进行过初级预防试验。我们建议进行 一项在美国进行的多领域阿尔茨海默病风险降低干预的试点研究，以最大限度地 可行性和实施潜力，我们建议在综合医疗保健中执行我们的试验 传送系统。此外，我们计划使用个性化干预，这在 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 风险因素变化最大。具体地说，我们建议随机选择200名高危老年人(年龄≥70 有主观认知障碍的人，在认知测试和≥2上的表现低于正常水平 我们干预的目标是可修改的危险因素)到两年的多领域阿尔茨海默氏症风险 减少研究(MARRS)干预或健康教育(HE)对照。在MARRS干预组， 该团队将与参与者合作制定个性化的行动计划，以解决降低风险的问题，包括 心血管风险管理；戒烟；体力、精神和社会活动；健康饮食； 改善睡眠质量和用药管理。我们研究的目标是收集关于 与HE相比，MARRS对2年认知减退率的影响(目标1)；比较阿尔茨海默氏症的变化 可修改的风险因素(目标2)；收集关于MARRS与HE对其他 与健康有关的重要成果(目标3)。我们还将比较识别高危患者的策略 为了这项研究和未来的研究。这一创新的试点试验将提供急需的信息，以支持未来 多点试验，最终目的是延缓或预防导致阿尔茨海默病的认知能力下降。

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.