A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment

IF 4.4 2区医学 Q1 CLINICAL NEUROLOGY

Annals of Clinical and Translational Neurology Pub Date : 2023-08-07 DOI:10.1002/acn3.51863

Mark Monane, Kim G. Johnson, B. Joy Snider, Raymond S. Turner, Jonathan D. Drake, Demetrius M. Maraganore, James L. Bicksel, Daniel H. Jacobs, Julia L. Ortega, Joni Henderson, Yan Jiang, Shuguang Huang, Justine Coppinger, Ilana Fogelman, Tim West, Joel B. Braunstein

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引用次数: 1

Abstract

Objective

The objective of this study was to examine clinicians' patient selection and result interpretation of a clinically validated mass spectrometry test measuring amyloid beta and ApoE blood biomarkers combined with patient age (PrecivityAD® blood test) in symptomatic patients evaluated for Alzheimer's disease (AD) or other causes of cognitive decline.

Methods

The Quality Improvement and Clinical Utility PrecivityAD Clinician Survey (QUIP I, ClinicalTrials.gov Identifier: NCT05477056) was a prospective, single-arm cohort study among 366 patients evaluated by neurologists and other cognitive specialists. Participants underwent blood biomarker testing and received an amyloid probability score (APS), indicating the likelihood of a positive result on an amyloid positron emission tomography (PET) scan. The primary study outcomes were appropriateness of patient selection as well as result interpretation associated with PrecivityAD blood testing.

Results

A 95% (347/366) concordance rate was noted between clinicians' patient selection and the test's intended use criteria. In the final analysis including these 347 patients (median age 75 years, 56% women), prespecified test result categories incorporated 133 (38%) low APS, 162 (47%) high APS, and 52 (15%) intermediate APS patients. Clinicians' pretest and posttest AD diagnosis probability changed from 58% to 23% in low APS patients and 71% to 89% in high APS patients (p < 0.0001). Anti-AD drug therapy decreased by 46% in low APS patients (p < 0.0001) and increased by 57% in high APS patients (p < 0.0001).

Interpretation

These findings demonstrate the clinical utility of the PrecivityAD blood test in clinical care and may have added relevance as new AD therapies are introduced.

Abstract Image

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大脑淀粉样蛋白的血液生物标志物测试影响认知障碍的临床评估

目的本研究的目的是检查临床医生对阿尔茨海默病（AD）或其他认知原因有症状患者的患者选择和临床验证的质谱测试结果的解释，该测试测量淀粉样蛋白β和ApoE血液生物标志物并结合患者年龄（PrecivityAD®血液测试）减少方法质量改进和临床实用精度AD临床医生调查（QUIP I，ClinicalTrials.gov Identifier:NCT05477056）是一项前瞻性单臂队列研究，由神经学家和其他认知专家对366名患者进行评估。参与者接受了血液生物标志物测试，并接受了淀粉样蛋白概率评分（APS），表明淀粉样蛋白正电子发射断层扫描（PET）结果呈阳性的可能性。主要研究结果是患者选择的适当性以及与PrecityAD血液检测相关的结果解释。结果临床医生的患者选择和测试的预期使用标准之间的一致率为95%（347/366）。最终分析包括这347名患者（中位年龄75岁年龄，56%为女性），预先指定的测试结果类别包括133名（38%）低APS、162名（47%）高APS和52名（15%）中等APS患者。在低APS患者中，临床医生的测试前和测试后AD诊断概率从58%变为23%，在高APS患者中从71%变为89%（p <； 0.0001）。低APS患者的抗AD药物治疗减少了46%（p <； 0.0001），并且在高APS患者中增加了57%（p <； 0.0001）。解释这些发现证明了PrecivityAD血液测试在临床护理中的临床实用性，并可能随着新的AD疗法的引入而增加相关性。

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

Annals of Clinical and Translational Neurology Medicine-Neurology (clinical)

CiteScore

9.10

自引率

1.90%

发文量

218

审稿时长

8 weeks

期刊介绍： Annals of Clinical and Translational Neurology is a peer-reviewed journal for rapid dissemination of high-quality research related to all areas of neurology. The journal publishes original research and scholarly reviews focused on the mechanisms and treatments of diseases of the nervous system; high-impact topics in neurologic education; and other topics of interest to the clinical neuroscience community.