Li Danni, Thomas Robin, Tsai Michael Y, Li Ling, Vock David M, Greimel Susan, Yu Fang
Department of Laboratory Medicine and Pathology, University of Minnesota, Twin Cities, Minneapolis, Minnesota, USA.
Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Twin Cities, Minneapolis, Minnesota, USA.
BMJ Open. 2016 Dec 30;6(12):e011054. doi: 10.1136/bmjopen-2016-011054.
Exercise interventions are a promising treatment for improving cognition in persons with Alzheimer's disease. This is similar to Alzheimer's disease pharmacotherapies in which only 18-48% of treated patients demonstrate improvement in cognition. Aerobic exercise interventions positively affect brain structure and function through biologically sound pathways. However, an under-studied mechanism of aerobic exercise's effects is n-3 fatty acids in plasma. The objective of this pilot study is to inform a future large-scale study to develop n-3 fatty acids-based prediction of cognitive responses to aerobic exercise treatment in Alzheimer's disease.
This study will recruit and follow a cohort of 25 subjects enrolled in the FIT-AD Trial, an ongoing randomised controlled trial that investigates the effects of a 6-month moderate-intensity cycling intervention on cognition and hippocampal volume in older adults with mild to moderate Alzheimer's disease over a year. This study will collect blood from subjects at baseline and at 3 and 6 months to assay vascular biomarkers (ie, plasma fatty acids). Global cognition as measured by the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) at baseline, 3, 6, 9 and 12 months will be used as the main outcome. A multiple linear-regression model will be used with 12-month change in cognition as the outcome and baseline measure of n-3 fatty acids or changes in the ratio of n-3 to n-6 fatty-acid levels in plasma at 3 and/or 6 months, randomised treatment group, and their interaction as predictors.
We have obtained Institutional Review Board approval for our study. We obtain consent or assent/surrogate consent from all subjects depending on their consenting capacity assessment. Data of this study are/will be stored in the Research Electronic Data Capture (REDCap). We plan to present and publish our study findings through presentations and manuscripts.
NCT01954550.
运动干预是改善阿尔茨海默病患者认知功能的一种很有前景的治疗方法。这与阿尔茨海默病药物治疗类似，在药物治疗中，只有18%至48%的患者认知功能得到改善。有氧运动干预通过合理的生物学途径对脑结构和功能产生积极影响。然而，有氧运动效果的一个研究不足的机制是血浆中的n-3脂肪酸。这项初步研究的目的是为未来的大规模研究提供信息，以开发基于n-3脂肪酸的阿尔茨海默病有氧运动治疗认知反应预测模型。
本研究将招募并跟踪25名参与FIT-AD试验的受试者，该试验是一项正在进行的随机对照试验，研究为期6个月的中等强度骑行干预对轻度至中度阿尔茨海默病老年患者认知功能和海马体积的影响，为期一年。本研究将在基线时以及3个月和6个月时从受试者采集血液，以检测血管生物标志物（即血浆脂肪酸）。在基线、3个月、6个月、9个月和12个月时，使用阿尔茨海默病评估量表-认知部分（ADAS-Cog）测量的总体认知功能将作为主要结局。将使用多元线性回归模型，以12个月时的认知变化为结局，以n-3脂肪酸的基线测量值或3个月和/或6个月时血浆中n-3与n-6脂肪酸水平的比值变化、随机治疗组及其相互作用作为预测因子。
我们已获得机构审查委员会对本研究的批准。我们根据所有受试者的同意能力评估获得其同意或同意/替代同意。本研究的数据已/将存储在研究电子数据采集（REDCap）中。我们计划通过报告和手稿展示并发表我们的研究结果。
NCT01954550。
