Return of Amyloid Imaging Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 主要终点
- Understanding of mild cognitive impairment as a potential precursor to dementia--knowledge
研究概览
简要总结
Diagnostic tests designed to detect 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 tests 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 will examine a well characterized sample of MCI care dyads (patient + family member) who will be randomized to either receive the opportunity to decide if they would like to pursue an amyloid PET Scan, or be randomized to not receive that opportunity (and will serve in the no-scan comparison group). This study aims to test hypotheses that examine how receiving amyloid imaging results will impact understanding of, and perceived self-efficacy for coping with, MCI among both patients and care partners.
详细描述
Objective:
Advances in amyloid imaging are leading to unprecedented changes in research on cognitive aging. We intend to characterize the way individuals respond to learning of the results of their amyloid imaging scans, understand the context in which decisions to obtain results of brain amyloid status are made, and examine the impact of such knowledge over the first year following results disclosure.
Specific Aim:
To determine the effect of receiving amyloid imaging results on understanding of, and perceived efficacy to cope with, Mild Cognitive Impairment (MCI) as a potential precursor to dementia.
Hypothesis 1. MCI care dyads who receive amyloid imaging results, using the text and visual aids developed by our interdisciplinary team, will a) perform better on objective assessments of basic knowledge about MCI and its relation to AD, and b) report lower levels of perceived ambiguity about what MCI means, as compared to control MCI care dyads not receiving amyloid imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All MCI participants:
- •Participant at the Pittsburgh Alzheimer's Disease Research Center, or other cognitive impairment studies.
- •Carry a current diagnosis of MCI
- •Have a family member or kin-like friend who also signs informed consent to participate
- •Female participants must be 5 years post menopausal by self-report
- •All family member participants:
- •At least 18 years of age 2) Can read and write English
排除标准
- •All MCI patient participants:
- •familial AD genetic mutation carriers (this group already has biomarker-derived knowledge of their dementia risk)
- •evidence of active, untreated primary psychiatric disorders defined as a CES-D (Depression Rating Scale) score of >=16 or a Spielberger State Anxiety score of >40 (to minimize the possibility of adverse events and to reduce any confounding influence of baseline mood)
- •Active suicidal ideation indicated via the Beck Scale for Suicidal Ideation and verified by clinician interview.
- •Participants with MCI and their primary participating family member:
- •Inability to provide direct consent to the study based on performance on the University of San Diego Brief Assessment of Capacity to Consent (meaning, proxy consent will not be accepted).
结局指标
主要结局
Understanding of mild cognitive impairment as a potential precursor to dementia--knowledge
时间窗: One month followup
Score on a knowledge questionnaire
Perceived efficacy to cope with mild cognitive impairment as a potential precursor to dementia
时间窗: One month followup
Score on Coping Self-Efficacy Scale
Understanding of mild cognitive impairment as a potential precursor to dementia-Coherence
时间窗: One month followup
Score on Brief Illness Perception Questionnaire Coherence Subscale
次要结局
未报告次要终点
研究者
Jennifer H. Lingler
Associate Professor
University of Pittsburgh