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Clinical Trial Alzheimer's research & therapy. 2019 May 1;11(1):36. doi: 10.1186/s13195-019-0484-1 Q17.62024

Effects of spermidine supplementation on cognition and biomarkers in older adults with subjective cognitive decline (SmartAge)-study protocol for a randomized controlled trial

一项关于无客观认知损害的主观认知下降老年人口服甜菜碱对认知和生物标志物影响的随机对照试验方案(SmartAge研究) 翻译改进

Miranka Wirth  1  2  3  4, Claudia Schwarz  1  2, Gloria Benson  1  2, Nora Horn  1  2, Ralph Buchert  5  6, Catharina Lange  5, Theresa Köbe  1  2  7  8, Stefan Hetzer  9  10, Marta Maglione  2  11, Eva Michael  2  11, Stefanie Märschenz  2, Knut Mai  12  13, Ute Kopp  1, Dietmar Schmitz  2  14, Ulrike Grittner  15  16, Stephan J Sigrist  2  11  14, Slaven Stekovic  17, Frank Madeo  18  19, Agnes Flöel  20  21

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作者单位

  • 1 Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Klinik und Hochschulambulanz für Neurologie, Berlin, Germany.
  • 2 Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, NeuroCure Clinical Research Center, Berlin, Germany.
  • 3 Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Center for Stroke Research Berlin, Berlin, Germany.
  • 4 German Center for Neurodegenerative Diseases (DZNE), Dresden, Germany.
  • 5 Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Nuclear Medicine, Berlin, Germany.
  • 6 University Hospital Hamburg-Eppendorf, Department of Diagnostic and Interventional Radiology and Nuclear Medicine, Hamburg, Germany.
  • 7 Douglas Mental Health University Institute, Studies on Prevention of Alzheimer's Disease (StOP-AD) Centre, Montreal, Quebec, Canada.
  • 8 Department of Psychiatry, McGill University, Montreal, Quebec, Canada.
  • 9 Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin Center for Advanced Neuroimaging, Berlin, Germany.
  • 10 Bernstein Center for Computational Neuroscience, Berlin, Germany.
  • 11 Institute for Biology/Genetics, Freie Universität Berlin, Berlin, Germany.
  • 12 Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Endocrinology & Metabolism, Berlin, Germany.
  • 13 Charité-Center for Cardiovascular Research (CCR), Berlin, Germany.
  • 14 German Center for Neurodegenerative Diseases (DZNE), Berlin, Germany.
  • 15 Charité - Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute of Biometry and Clinical Epidemiology, Berlin, Germany.
  • 16 Berlin Institute of Health (BIH), Berlin, Germany.
  • 17 Institute of Molecular Biosciences, University of Graz, NAWI Graz, Graz, Austria.
  • 18 Institute of Molecular Biosciences, University of Graz, NAWI Graz, Graz, Austria. frank.madeo@uni-graz.at.
  • 19 BioTechMed, Graz, Austria. frank.madeo@uni-graz.at.
  • 20 Department of Neurology, University Medicine Greifswald, Greifswald, Germany. agnes.floeel@uni-greifswald.de.
  • 21 German Center for Neurodegenerative Diseases (DZNE), Rostock/Greifswald, Rostock, Germany. agnes.floeel@uni-greifswald.de.

    • DOI: 10.1186/s13195-019-0484-1 PMID: 31039826

    摘要 Ai翻译

    Background: Given the global increase in the aging population and age-related diseases, the promotion of healthy aging is one of the most crucial public health issues. This trial aims to contribute to the establishment of effective approaches to promote cognitive and brain health in older individuals with subjective cognitive decline (SCD). Presence of SCD is known to increase the risk of objective cognitive decline and progression to dementia due to Alzheimer's disease. Therefore, it is our primary goal to determine whether spermidine supplementation has a positive impact on memory performance in this at-risk group, as compared with placebo. The secondary goal is to examine the effects of spermidine intake on other neuropsychological, behavioral, and physiological parameters.

    Methods: The SmartAge trial is a monocentric, randomized, double-blind, placebo-controlled phase IIb trial. The study will investigate 12 months of intervention with spermidine-based nutritional supplementation (target intervention) compared with 12 months of placebo intake (control intervention). We plan to recruit 100 cognitively normal older individuals with SCD from memory clinics, neurologists and general practitioners in private practice, and the general population. Participants will be allocated to one of the two study arms using blockwise randomization stratified by age and sex with a 1:1 allocation ratio. The primary outcome is the change in memory performance between baseline and post-intervention visits (12 months after baseline). Secondary outcomes include the change in memory performance from baseline to follow-up assessment (18 months after baseline), as well as changes in neurocognitive, behavioral, and physiological parameters (including blood and neuroimaging biomarkers), assessed at baseline and post-intervention.

    Discussion: The SmartAge trial aims to provide evidence of the impact of spermidine supplementation on memory performance in older individuals with SCD. In addition, we will identify possible neurophysiological mechanisms of action underlying the anticipated cognitive benefits. Overall, this trial will contribute to the establishment of nutrition intervention in the prevention of Alzheimer's disease.

    Trial registration: ClinicalTrials.gov, NCT03094546 . Registered 29 March 2017-retrospectively registered.

    Protocol version: Based on EA1/250/16 version 1.5.

    Keywords: Aging; Autophagy; Dietary supplementation; Health; Memory; Nutrition; Polyamines.

    Keywords：spermidine supplementation; cognitive decline; randomized controlled trial

    关键词：spermidine补充; 认知衰退; 随机对照试验

    Copyright © Alzheimer's research & therapy. 中文内容为AI机器翻译，仅供参考！

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    期刊名：Alzheimers research & therapy

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    ISSN：N/A

    e-ISSN：1758-9193

    IF/分区：7.6/Q1

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    Effects of spermidine supplementation on cognition and biomarkers in older adults with subjective cognitive decline (SmartAge)-study protocol for a randomized controlled trial