Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Department of Medicine, Division of General Internal Medicine and Geriatrics, Indiana University School of Medicine, Indianapolis, IN, United States of America.
Indiana University Center for Aging Research, Indianapolis, IN, United States of America; Regenstrief Institute, Inc., Indianapolis, IN, United States of America; Indiana University Richard M. Fairbanks School of Public Health, Indianapolis, IN, United States of America.
Contemp Clin Trials. 2019 Sep;84:105814. doi: 10.1016/j.cct.2019.105814. Epub 2019 Jul 18.
Multiple national organizations and leaders have called for increased attention to dementia prevention in those most vulnerable, for example persons with limited formal education. Prevention recommendations have included calls for multicomponent interventions that have the potential to improve both underlying neurobiological health and the ability to function despite neurobiological pathology, or what has been termed cognitive reserve.
Test feasibility, treatment modifier, mechanism, and cognitive function effects of a multicomponent intervention consisting of foods high in polyphenols (i.e., MIND foods) to target neurobiological health, and speed of processing training to enhance cognitive reserve. We refer to this multicomponent intervention as MINDSpeed.
MINDSpeed is being evaluated in a 2 × 2 randomized factorial design with 180 participants residing independently in a large Midwestern city. Qualifying participants are 60 years of age or older with no evidence of dementia, and who have completed 12 years or less of education. All participants receive a study-issued iPad to access the custom study application that enables participants, depending on randomization, to select either control or MIND food, and to play online cognitive games, either speed of processing or control games.
All participants complete informed consent and baseline assessment, including urine and blood samples. Additionally, up to 90 participants will complete neuroimaging. Assessments are repeated immediately following 12 weeks of active intervention, and at 24 weeks post-randomization. The primary outcome is an executive cognitive composite score. Secondary outcomes include oxidative stress, pro-inflammatory cytokines, and neuroimaging-captured structural and functional metrics of the hippocampus and cortical brain regions.
MINDSpeed is the first study to evaluate the multicomponent intervention of high polyphenol intake and speed of processing training. It is also one of the first dementia prevention trials to target older adults with low education. The results of the study will guide future dementia prevention efforts and trials in high risk populations.
多个国家组织和领导人呼吁加强对最弱势群体（例如受正规教育程度有限的人群）的痴呆症预防工作的关注。预防建议包括呼吁采取多组分干预措施，这些措施有可能改善潜在的神经生物学健康状况，并增强在神经生物学病理学存在下的功能，或者被称为认知储备。
测试一种多组分干预措施（包括富含多酚的食物，即 MIND 食物，以针对神经生物学健康，以及进行加工速度训练以增强认知储备）的可行性、治疗修饰剂、机制和认知功能效果。我们将这种多组分干预措施称为 MINDSpeed。
MINDSpeed 正在一项 2×2 随机析因设计中进行评估，该设计有 180 名参与者独立居住在一个中西部大城市中。符合条件的参与者年龄在 60 岁或以上，没有痴呆症的证据，并且完成了 12 年或以下的教育。所有参与者都获得了一个研究发行的 iPad 来访问定制的研究应用程序，根据随机分配，参与者可以选择控制或 MIND 食物，以及玩在线认知游戏，是速度处理游戏或控制游戏。
所有参与者都完成知情同意书和基线评估，包括尿液和血液样本。此外，多达 90 名参与者将完成神经影像学检查。评估在 12 周的积极干预后立即重复进行，并在随机分组后 24 周重复进行。主要结局是执行认知综合评分。次要结局包括氧化应激、促炎细胞因子以及捕获海马体和皮质脑区的结构和功能指标的神经影像学。
MINDSpeed 是评估高多酚摄入量和加工速度训练的多组分干预措施的第一项研究。它也是针对低教育程度的老年人群进行的第一个痴呆症预防试验之一。该研究的结果将指导未来高危人群的痴呆症预防工作和试验。
