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Vascular biomarkers to predict response to exercise in Alzheimer's disease: the study protocol
  1. Danni Li1,
  2. Robin Thomas1,
  3. Michael Y Tsai1,
  4. Ling Li2,
  5. David M Vock3,
  6. Susan Greimel4,
  7. Fang Yu4
  1. 1Department of Laboratory Medicine and Pathology, University of Minnesota, Twin Cities, Minneapolis, Minnesota, USA
  2. 2Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Twin Cities, Minneapolis, Minnesota, USA
  3. 3Division of Biostatistics, School of Public Health, University of Minnesota, Twin Cities, Minneapolis, Minnesota, USA
  4. 4School of Nursing, University of Minnesota, Twin Cities, Minneapolis, Minnesota, USA
  1. Correspondence to Dr Danni Li; dannili{at}umn.edu

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number NCT01954550.

  • Exercise
  • Alzheimer’s disease
  • Vascular biomarkers
  • Fatty Acids
  • Phospholipids

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors DL designed and supervises all aspects of the study, and drafted the manuscript. RT contributed to the draft of the manuscript. MT supervises plasma fatty acids analysis and contributed to the draft of the manuscript. LL contributed to the draft of the manuscript and provided feedback to the design of the study. SG contributed to the draft of the manuscript. DV contributed to the draft of the manuscript, provided feedback to the design of the study, and designed the statistical analysis plan. FA contributed to the draft of the manuscript and provided significant feedback to the design of the study. All authors read and approved the final manuscript.

  • Funding This study is funded by the Alzheimer's Association (NIGR-15-362392, 1 December 2015 to 30 November 2017).

  • Competing interests None declared.

  • Ethics approval This study was approved by the UMN’s IRB: # 1508M77566.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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