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: 9967929
• 负责人: DANIEL O CLARK
• 金额: $ 70.1万
• 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 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9967929
• 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，医学研究所呼吁临床试验和多组分 预防高危成人认知能力下降的干预措施。我们在此提议 高多酚食物与加工速度认知训练相结合的随机试验 低学历的老年人。 教育程度低是阿尔茨海默病（AD）的最大可改变风险因素。低 认知储备是低教育对早期认知能力下降影响的主要假设。 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。随机试验表明，仅仅12周的 食用MIND食品可以改善短期认知，包括加工速度。 同样，12周的处理速度训练具有广泛的效果， 被假设为提高认知储备。我们对现有试验数据的二次分析 研究表明，认知训练的效果在受教育程度低的人中最大。此时， 目前还没有发表的关于低血糖老年人处理速度训练的试验。 教育也没有任何试验的加工速度培训结合心灵食品。 使用2 × 2析因设计，我们提出了一个随机对照试验的有效性， 速度训练和精神食品在维持或改善老年人的大脑和认知健康方面的作用 受教育程度低且无痴呆症的成年人。寻求初级保健的老年人， 教育将被招募并随机分配到四个组中的一个：MIND食物+速度训练， MIND食物+速度训练控制，MIND食物控制+速度训练，或MIND食物控制+ 速度训练控制。我们将MIND和Speed组合称为MINDSeed，而 MIND食物控制和速度训练控制的组合，我们称之为双重控制。 12周的访问，支持，培训和食物的激励措施将得到促进， 由我们的用户界面设计团队与用户一起创建的平板电脑应用程序。主要具体 这项试点临床试验的目的是确定MINDSeed对执行认知的影响， 相对于双重对照的复合（ECC）评分。第二个目标是确定：1）心智 和速度对ECC的治疗效果与双控制和MINDSpeed，2）可行性（即， 依从性、满意度、不良事件、成本），3）治疗效果调节剂（例如，教育、 年龄、基线认知状态、APOE ε4携带状态），和4）炎症机制， 氧化应激和海马体积。这项研究的最终目标是 通过MIND食物和大脑训练增强认知储备，从而延缓AD。