Return of Amyloid Imaging Research Results in MCI

MCI 淀粉样蛋白成像研究结果返回

• 批准号: 9094407
• 负责人: JENNIFER Hagerty LINGLER
• 金额: $ 38.11万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-01 至 2018-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9094407
• 关键词: Alzheimer' s Disease; Amyloid; Amyloid beta-Protein; Autopsy; Behavioral; Behavioral Research; Biological Markers; Brain; Caring; Clinical; Clinical Research; Cognitive aging; Consent; Data; Dementia; Disclosure; Emerging Technologies; Ethical Issues; Family; Family member; Frequencies; Future; Goals; Health; Image; Imaging technology; Individual; Intervention; Interview; Knowledge; Lead; Learning; Nature; Participant; Pathology; Patient Care; Patients; Persons; Pharmacotherapy; Population; Prevention strategy; Process; Public Health; Reaction; Recruitment Activity; Reporting; Research; Research Personnel; Research Subjects; Risk; Sample Size; Sampling; Scanning; Secondary Prevention; Self Efficacy; Series; Staging; Subgroup; Syndrome; Techniques; Technology; Testing; Text; Time; United States Food and Drug Administration; Visit; Visual; Visual Aid; Work; amyloid imaging; base; behavioral response; clinical practice; clinically significant; comparison group; coping; evidence base; expectation; follow-up; imaging agent; improved; in vivo; interest; mild cognitive impairment; neuroimaging; new technology; prognostic; programs; psychologic; research clinical testing; response; social

DESCRIPTION (provided by applicant): Pre mortem tests of Alzheimer's disease (AD) pathology are increasingly popular in research on cognitive aging and AD. Due to concerns that information from such tests may be misunderstood, psychologically harmful, and of unclear clinical significance, results of pre mortem tests of AD pathology have typically been withheld from research participants. However, as the reliability and potential clinical significance of test like brain amyloid imaging have become clear, there is a pressing need to revisit the practice of unilaterally withholding such information from research participants and identify responsible approaches to communicating individual results. Amyloid imaging results may be particularly relevant to mild cognitive impairment (MCI), a population for whom a growing body of evidence suggests that such testing may provide valuable prognostic and planning information, despite the unavailability of interventions to alter one's clinical course. Our preliminary work suggests that research participants with MCI and their family members are receptive to and capable of understanding information about the purpose, results, and implications of amyloid imaging when presented using a standardized approach developed by our interdisciplinary team. Building on this work, the proposed study, led by an early stage investigator in response to PA-11-180, will follow a well characterized sample of at least 40 MCI care dyads (patient + family member) who are, and a matched comparison group of dyads who are not, presented with the option of receiving the patient's amyloid imaging research results. Aim 1 will test hypotheses that examine how receiving amyloid imaging research results will impact understanding of, and perceived self-efficacy for coping with, MCI among both patients and care partners. Aim 2 will use a series of qualitative interviews and content analysis to identify the information and support needs of MCI care dyads who are offered amyloid imaging research results. A third, exploratory aim will document, within the subgroup of MCI care dyads who receive amyloid imaging research results, the frequency, nature, and range of psychological and behavioral responses to receiving such results. In addition to having implications for research conduct, our findings may also inform clinical practice as clinicians begin to incorporate amyloid imaging into clinical evaluation and respond to patient requests for such imaging.

描述（由申请人提供）：阿尔茨海默病（AD）病理学的尸检测试在认知衰老和AD的研究中越来越受欢迎。由于担心这些测试的信息可能会被误解，心理上有害，临床意义不明，AD病理学的尸检前测试结果通常被扣留的研究参与者。然而，随着脑淀粉样蛋白成像等测试的可靠性和潜在临床意义变得越来越清晰，迫切需要重新审视单方面向研究参与者隐瞒此类信息的做法，并确定负责任的方法来传达个人结果。淀粉样蛋白成像结果可能与轻度认知障碍（MCI）特别相关，尽管无法通过干预措施改变临床病程，但越来越多的证据表明，这种检测可能提供有价值的预后和计划信息。我们的初步工作表明，MCI研究参与者及其家庭成员接受并能够理解有关淀粉样蛋白成像的目的，结果和影响的信息，当使用我们的跨学科团队开发的标准化方法时。在这项工作的基础上，由早期研究者领导的对PA-11-180的响应的拟议研究将遵循至少40个MCI护理二人组（患者+家庭成员）的良好表征样本，以及一个匹配的二人组对照组，他们没有选择接受患者的淀粉样蛋白成像研究结果。目标1将测试假设，研究如何接收淀粉样蛋白成像研究结果将影响理解，并感知自我效能，应对MCI患者和护理伙伴。目标2将使用一系列定性访谈和内容分析来确定信息和支持 MCI护理二人组的需求，提供淀粉样蛋白成像研究结果。第三，探索性的目标将记录，在MCI护理二人组谁收到淀粉样蛋白成像研究结果，频率，性质和范围的心理和行为反应，以接收这样的结果。除了对研究行为有影响外，我们的发现还可能为临床实践提供信息，因为临床医生开始将淀粉样蛋白成像纳入临床评估并对患者的此类成像要求做出回应。