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溢出效应:阿尔茨海默病痴呆症新药的批准将影响无症状研究参与者的生物标志物披露。

Spillover: The Approval of New Medications for Alzheimer's Disease Dementia Will Impact Biomarker Disclosure Among Asymptomatic Research Participants.

机构信息

Bioethics Research Center, Division of General Medical Sciences, Washington University School of Medicine, St.Louis, MO, USA.

Department of Health Behavior & Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA.

出版信息

J Alzheimers Dis. 2022;90(3):1035-1043. doi: 10.3233/JAD-220113.

Abstract

In this article we address how the recent, and anticipated upcoming, FDA approvals of novel anti-amyloid medications to treat individuals with mild Alzheimer's disease (AD) dementia could impact disclosure of biomarker results among asymptomatic research participants. Currently, research is typically the context where an asymptomatic individual may have the option to learn their amyloid biomarker status. Asymptomatic research participants who learn their amyloid status may have questions regarding the meaning of this result and the implications for accessing a potential intervention. After outlining our rationale, we provide examples of how current educational materials used in research convey messages regarding amyloid positivity and the availability of treatments, or lack thereof. We suggest language to improve messaging, as well as strengths of current materials, in addressing these issues for research participants. Although novel medications are currently only approved for use among symptomatic individuals, their availability may have implications for disclosure among asymptomatic research participants with evidence of amyloid deposition, who may be especially interested in information on these interventions for potential prevention, or future treatment, of mild cognitive impairment or dementia due to AD.

摘要

在本文中,我们将探讨最近以及预期即将获得美国食品和药物管理局(FDA)批准的新型抗淀粉样蛋白药物治疗轻度阿尔茨海默病(AD)痴呆症患者,这将如何影响无症状研究参与者中生物标志物结果的披露。目前,研究通常是无症状个体可以选择了解其淀粉样蛋白生物标志物状态的环境。了解其淀粉样蛋白状态的无症状研究参与者可能会对该结果的含义以及获得潜在干预措施的意义提出疑问。在概述我们的基本原理之后,我们提供了研究中当前使用的教育材料如何传达有关淀粉样蛋白阳性和治疗方法(或缺乏治疗方法)的信息的示例。我们建议使用改进的语言来传达信息,以及当前材料的优势,以解决研究参与者的这些问题。尽管新型药物目前仅批准用于有症状的个体,但它们的可用性可能会对有淀粉样蛋白沉积证据的无症状研究参与者的披露产生影响,这些参与者可能特别关注这些干预措施的信息,以预防或未来治疗 AD 引起的轻度认知障碍或痴呆。

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