Neuropsychological, Psychiatric, and Functional Correlates of Clinical Trial Enrollment

IF 8.5 3区医学 Q1 CLINICAL NEUROLOGY

Jpad-Journal of Prevention of Alzheimers Disease Pub Date : 2019-01-01 DOI:10.14283/jpad.2019.38

D. Hammers, Norman L. Foster, J. Hoffman, T. Greene, Kevin Duff

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引用次数: 2

Abstract

Screen failure rates in Alzheimer’s disease (AD) clinical trial research are unsustainable, with participant recruitment being a top barrier to AD research progress. The purpose of this project was to understand the neuropsychological, psychiatric, and functional features of individuals who failed screening measures for AD trials. Previously collected clinical data from 38 patients (aged 50–83) screened for a specific industry-sponsored clinical trial of MCI/early AD (Biogen 221AD302, [EMERGE]) were analyzed to identify predictors of AD trial screen pass/fail status. Worse performance on non-memory cognitive domains like crystalized knowledge, executive functioning, and attention, and higher self-reported anxiety, was associated with failing the screening visit for the EMERGE AD clinical trial, whereas we were not able to detect a relationship between screening status and memory performance, self-reported depression, or self-reported daily functioning. By identifying predictors of AD trial screen passing/failure, this research may influence decision-making about which patients are most likely to successfully enroll in a trial, thereby potentially lowering participant burden, maximizing study resources, and reducing costs.

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临床试验入组的神经心理学、精神病学和功能相关性

阿尔茨海默病(AD)临床试验研究的筛查失败率是不可持续的，参与者招募是阿尔茨海默病研究进展的最大障碍。该项目的目的是了解未通过阿尔茨海默病试验筛查措施的个体的神经心理学、精神病学和功能特征。先前收集的38例患者(50-83岁)的临床数据进行了分析，筛选MCI/早期AD (Biogen 221AD302， [EMERGE])的特定行业赞助的临床试验，以确定AD试验筛选通过/失败状态的预测因素。在非记忆认知领域，如明确知识、执行功能和注意力方面的较差表现，以及较高的自我报告焦虑，与未通过EMERGE AD临床试验的筛查有关，而我们无法发现筛查状态与记忆表现、自我报告的抑郁或自我报告的日常功能之间的关系。通过确定AD试验筛选通过/失败的预测因素，本研究可能会影响哪些患者最有可能成功参加试验的决策，从而潜在地降低参与者负担，最大化研究资源，并降低成本。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Jpad-Journal of Prevention of Alzheimers Disease CLINICAL NEUROLOGY-

自引率

7.80%

发文量

期刊介绍： The JPAD « Journal of Prevention of Alzheimer’Disease » will publish reviews, original research articles and short reports to improve our knowledge in the field of Alzheimer prevention including : neurosciences, biomarkers, imaging, epidemiology, public health, physical cognitive exercise, nutrition, risk and protective factors, drug development, trials design, and heath economic outcomes. JPAD will publish also the meeting abstracts from Clinical Trial on Alzheimer Disease (CTAD) and will be distributed both in paper and online version worldwide.