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

针对低教育程度老年人的 MIND 食物和加工速度培训，MINDSpeed 阿尔茨海默病预防试点试验

• 批准号: 10425221
• 负责人: DANIEL O CLARK
• 金额: $ 66.6万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-15 至 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10425221
• 关键词: Adherence; Adult; Adverse event; Age; Aging; Alzheimer disease prevention; Alzheimer' s Disease; Alzheimer' s disease risk; Behavior; Brain; Caring; Clinical Trials; Cognition; Cognitive; Cognitive aging; Complex; Consent; Consumption; Data; Data Analyses; Dementia; Diet; Diet Habits; Dietary Component; Education; Educational Intervention; Elderly; Electronic Health Record; Environment; Epidemiology; Evaluation; Federally Qualified Health Center; Food; Goals; Health; Health Food; Hippocampus (Brain); Impaired cognition; Incentives; Inflammation; Institute of Medicine (U.S.); Intervention; Lead; Learning; Length; Liquid substance; Measures; Memory; Neurons; Onset of illness; Oxidative Stress; Participant; Performance; Polyunsaturated Fatty Acids; Population; Prevention trial; Primary Health Care; Process; Provider; Psyche structure; Publishing; Randomized; Randomized Controlled Trials; Reporting; Research; Risk; Risk Factors; Role; Running; Speed; Tablets; Testing; Time; Training; Vulnerable Populations; apolipoprotein E-4; arm; care seeking; carrier status; cognitive enhancement; cognitive reserve; cognitive training; combinatorial; cost; design; efficacy trial; follow-up; improved; low socioeconomic status; modifiable risk; multi-component intervention; neural network; neurogenesis; pilot trial; polyphenol; prevent; processing speed; programs; randomized trial; recruit; satisfaction; secondary analysis; treatment effect

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.

2015年4月，医学研究所呼吁进行临床试验和多组件 防止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 高多酚食品的随机试验与加工认知训练的速度相结合 在接受低教育的老年人中。 低教育是阿尔茨海默氏病（AD）的最佳修改风险因素。低的 认知储备是低教育对早期认知能力下降的影响的主要假设。 特定的饮食成分，这里称为“思维食品”，已成为关键 增强认知储备的干预措施。随机试验支持仅12周 精神食品的消费改善了短期认知，包括加工速度。 同样，加工训练的速度为12周有广泛的影响，并且已经 假设可以改善认知储备。我们对现有试验数据的次要分析 表明认知训练的效果在低等教育的人中最大。此时， 在低较低的老年人中，没有公开的处理速度培训速度的试验 教育也没有任何加工训练速度和心灵食品的试验。 使用2 x 2阶乘设计，我们提出了一项关于效率的随机对照试验 速度训练和心灵食物在维持或改善大脑和认知健康的老年人中 受教育低下的成年人，没有痴呆症。老年人寻求低位的初级保健 教育将被招募并随机分为四个武器之一：心理食物 +速度训练， 心灵食品 +速度训练控制，心理控制 +速度训练或心理食物控制 + 速度训练控制。我们将思维和速度组合称为Mindspeed，而 精神控制和速度训练控制的组合我们称为双重控制。 培训和食物的访问，支持和激励措施将由十二周 平板电脑应用程序由我们的用户界面设计团队与用户创建。主要特异性 该试点临床试验的目的是确定对执行认知能力的思维速度影响 相对于双重控制，复合（ECC）得分。次要目的是确定：1​​） 以及对ECC与双重控制和思维速度的速度治疗效果，2）可行性（即 遵守，满意度，广告事件，成本），3）治疗效果修饰符（例如，教育， 年龄，基线认知状况，APOEε4载体状态）和4）炎症机制， 氧化应激和海马体积。这一研究的最终目标是 通过思维食品和大脑训练增强认知储备，从而延迟广告。