Novel approaches to measuring neurocognitive functions in Alzheimer's disease clinical trials.
Novel approaches to measuring neurocognitive functions in Alzheimer's disease clinical trials.
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在阿尔茨海默氏病临床试验中测量神经认知功能的新方法。
DOI：
10.1097/wco.0000000000001041
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发表时间：
2022-04-01
影响因子：
4.8
通讯作者：
Goldberg, Terry E.
中科院分区：
文献类型：
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作者：
Carlson, Scott;Kim, Hyun;Devanand, Davangere P.;Goldberg, Terry E.
我们全面研究了开发新型认知测量的最新进展，这些测量可以显着增强对阿尔茨海默病 (AD) 临床试验结果变化的检测。先前制定的措施在很大程度上限制了检测 AD 临床前阶段微妙的认知能力下降的能力，特别是由于心理测量特性较弱（包括实践效应和上限效应）以及影响确定的亲自访问的要求。我们提出了新颖的认知测量方法，旨在展示减少的实践效果以及与 AD 生物标志物更强的相关性。此外，我们总结了最近在开发远程测试措施协议方面的一些努力，这些协议旨在克服现场测试和数字表型的限制和不便，数字表型分析表明认知表型的数字行为的微妙形式。我们讨论了每项措施的预后准确性和 AD 研究中的潜在效用，同时也评论了它们的局限性。我们还描述了我们的研究，即阿尔茨海默病预防试验新措施的开发（NoMAD），该研究采用平行组设计，在临床试验框架中对新措施和既定措施进行比较。总体而言，我们相信这些最新进展为准确检测 AD 谱系中的临床和临床前认知变化提供了有希望的改进；然而，在 AD 临床试验中可靠地实施这些新措施之前，需要进一步验证其心理测量特性和诊断准确性。
We comprehensively examined recent advancements in developing novel cognitive measures that could significantly enhance detection of outcome changes in Alzheimer’s disease (AD) clinical trials. Previously established measures were largely limited in their ability to detect subtle cognitive declines in preclinical stages of AD, particularly due to weak psychometric properties (including practice effects and ceiling effects) and requirement of in-person visits that impacted ascertainment. We present novel cognitive measures that were designed to exhibit reduced practice effects and stronger correlations with AD biomarkers. Additionally, we summarized some recent efforts in developing remote testing measures protocols that are aimed to overcome the limitations and inconvenience of in-person testing, and digital phenotyping, which analyzes subtle forms of digital behavior indicative of cognitive phenotypes. We discuss each measure’s prognostic accuracy and potential utility in AD research while also commenting on their limitations. We also describe our study, the Development of Novel Measures for Alzheimer’s Disease Prevention Trials (NoMAD), that employed a parallel group design in which novel measures and established measures are compared in a clinical trials armature. Overall, we believe that these recent developments offer promising improvements in accurately detecting clinical and preclinical cognitive changes in the AD spectrum; however, further validation of their psychometric properties and diagnostic accuracies are warranted before reliably implementing these novel measures in AD clinical trials.
DOI：
10.3390/s18030926
发表时间：
2018-03-20
期刊：
Sensors (Basel, Switzerland)
影响因子：
--
作者：
Zhou H;Lee H;Lee J;Schwenk M;Najafi B
通讯作者：
Najafi B