MIND Food and Speed of Processing Training in Older Adults with Low Education, The MINDSpeed Alzheimer's Disease Prevention Pilot Trial

2015年4月，医学研究所呼吁进行临床试验和多组分 预防高危成年人认知能力下降的干预措施。我们在这里提议一名飞行员 高多酚食物结合加工速度认知训练的随机试验 在教育程度较低的老年人中。 低教育程度是阿尔茨海默病(AD)的首要可改变风险因素。低 认知储备是低教育程度对早期认知衰退影响的主要假说。 特定的饮食成分，在这里被称为“精神食品”，已经成为关键 增强认知储备的干预措施。随机试验只支持了12周的 食用精神类食物可以提高短期认知能力，包括处理速度。 同样，12周的处理速度训练具有广泛的效果，并已 假想是为了提高认知储备。我们对现有试验数据的二次分析 研究表明，低教育程度的人接受认知训练的效果最大。在这个时候， 在患有低血压病的老年人中，还没有发表过关于处理速度训练的试验 教育也没有任何关于处理训练与心智食物相结合的速度的试验。 采用2×2析因设计，我们提出了一项随机对照试验 速度训练和精神食品在维持或改善老年人大脑和认知健康方面的作用 受教育程度低且未患痴呆症的成年人。寻求初级保健的老年人 教育将被招募并随机分配到四个方面之一：精神食品+速度训练， 精神食品+速度训练控制，精神食品控制+速度训练，或精神食品控制+ 速度训练控制。我们将思维和速度的组合称为思维速度，而 头脑饮食控制和速度训练控制相结合，我们称之为双重控制。 将通过以下方式促进为期12周的培训和食物的获取、支持和奖励 由我们的用户界面设计团队与用户共同创建的平板电脑应用程序。主要的具体内容 这项先导性临床试验的目的是确定MINDSPEED对执行者认知的影响 相对于双重对照的综合(ECC)分数。次要目标是决定：1)思想 和速度处理对ECC与双重控制和MINDSPEED的影响，2)可行性(即， 依从性、满意度、不良事件、成本)，3)治疗效果修饰物(例如，教育， 年龄、基线认知状态、载脂蛋白Eε4携带者状态)以及4)炎症机制， 氧化应激，和海马体体积。这一系列研究的最终目标是 通过智力食品和大脑训练来增强认知储备，从而延缓AD。

In April 2015, the Institute of Medicine called for clinical trials and multi-component interventions to prevent cognitive decline among at-risk adults. We here propose a pilot randomized trial of high polyphenol foods combined with speed of processing cognitive training in older adults with low education. Low education is the top modifiable risk factor for Alzheimer disease (AD). Low cognitive reserve is a leading hypothesis for low education's effects on early cognitive decline. Specific dietary components, here referred to as "MIND foods,” have emerged as key interventions for enhancing cognitive reserve. Randomized trials support that just 12 weeks of consumption of MIND foods improves short-term cognition, including speed of processing. Similarly, 12 weeks of speed of processing training has broad effects and has been hypothesized to improve cognitive reserve. Our secondary analysis of existing trial data showed that cognitive training effects were largest in those with low education. At this time, there are no published trials of speed of processing training among older adults with low education nor are there any trials of speed of processing training combined with MIND foods. Using a 2 x 2 factorial design, we propose a randomized controlled trial of the efficacy of speed training and MIND foods in maintaining or improving brain and cognitive health in older adults with low education and no dementia. Older adults seeking primary care who have low education will be recruited and randomized to one of four arms: MIND food + Speed training, MIND food + Speed training control, MIND food control + Speed training, or MIND food control + Speed training control. We refer to the MIND and Speed combination as MINDSpeed, while the combination of MIND food control and speed training control we refer to as Double Control. Twelve weeks of access, support, and incentives for trainings and food will be facilitated by tablet applications created with users by our user-interface design team. The primary specific aim of this pilot clinical trial is to determine MINDSpeed effects on an executive cognitive composite (ECC) score relative to Double Control. Secondary aims are to determine: 1) MIND and Speed treatment effects on ECC vs Double Control and MINDSpeed, 2) feasibility (i.e., adherence, satisfaction, adverse events, costs), 3) treatment effect modifiers (e.g., education, age, baseline cognitive status, APOE ε4 carrier status), and 4) mechanisms of inflammation, oxidative stress, and hippocampal volume. The ultimate goal of this line of research is to enhance cognitive reserve through MIND foods and brain training and thereby delay AD.