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阿尔茨海默病血液检测在认知障碍患者中的临床应用:质量改进PrecivityAD2(QUIP II)临床医生调查研究结果

Clinical Utility of an Alzheimer's Disease Blood Test Among Cognitively Impaired Patients: Results from the Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey Study.

作者信息

Monane Mark, Maraganore Demetrius M, Carlile Robert M, Johnson Kim G, Merrill David A, Gitelman Darren R, Sharlin Kenneth S, VandeVrede Lawren A, George Kristi K, Wang Jimin, West Tim, Jacobs Leslie, Verghese Philip B, Braunstein Joel B

机构信息

C2N Diagnostics, LLC, 4340 Duncan Avenue, St. Louis, MO 63110, USA.

Department of Neurology, Tulane University School of Medicine, New Orleans, LA 70112, USA.

出版信息

Diagnostics (Basel). 2025 Jan 13;15(2):167. doi: 10.3390/diagnostics15020167.

Abstract

: The objective of this study was to assess clinical decision-making associated with the use of a multi-analyte blood biomarker (BBM) test among patients presenting with signs or symptoms of mild cognitive impairment or dementia. : The Quality Improvement PrecivityAD2 (QUIP II) Clinician Survey (NCT06025877) study evaluated the clinical utility of the PrecivityAD2™ blood test in a prospective, single cohort of 203 patients presenting with symptoms of Alzheimer's disease (AD) or other causes of cognitive decline across 12 memory specialists. The PrecivityAD2 blood test (C2N Diagnostics, St. Louis, MO) combines the plasma Aβ42/Aβ40 ratio and the p-tau217/np-tau217 ratio (%p-tau217) measurements in a statistical algorithm to yield an Amyloid Probability Score 2 (APS2) that informs on the likelihood of brain amyloid plaques. After receiving the BBM test results, clinicians completed surveys on management strategies for each patient. : Patients had a median age of 74, 53% were female, and 28% were traditionally under-represented in Black, Hispanic, and Asian groups. The composite primary endpoint, defined as a change in AD diagnostic certainty, drug therapy, or additional brain amyloid evaluation pre- and post-BBM testing, was 75% ( < 0.0001 versus the pre-specified threshold of 20% clinically meaningful change). Anti-AD medication orders decreased among negative APS2 patients and increased among positive APS2 patients ( < 0.0001). Additional brain amyloid testing decreased among negative APS2 patients ( < 0.0001). This blood biomarker test can help memory specialists guide patients to anti-AD therapies as well as rule out AD to allow for other diagnostic considerations.

摘要

本研究的目的是评估在出现轻度认知障碍或痴呆体征或症状的患者中,使用多分析物血液生物标志物(BBM)检测相关的临床决策。质量改进PrecivityAD2(QUIP II)临床医生调查(NCT06025877)研究在一个前瞻性单队列的203例出现阿尔茨海默病(AD)症状或其他认知衰退原因的患者中,评估了PrecivityAD2™血液检测的临床效用,该队列涉及12名记忆专家。PrecivityAD2血液检测(C2N Diagnostics,密苏里州圣路易斯)在一种统计算法中结合了血浆Aβ42/Aβ40比值和p-tau217/np-tau217比值(%p-tau217)测量值,以产生淀粉样蛋白概率评分2(APS2),该评分可告知脑淀粉样斑块的可能性。在收到BBM检测结果后,临床医生完成了关于每位患者管理策略的调查。患者的中位年龄为74岁,53%为女性,28%为黑人、西班牙裔和亚裔群体中传统上代表性不足的人群。复合主要终点定义为BBM检测前后AD诊断确定性、药物治疗或额外脑淀粉样蛋白评估的变化,为75%(与预先设定的20%临床有意义变化的阈值相比,P<0.0001)。APS2阴性的患者中抗AD药物处方减少,APS2阳性的患者中抗AD药物处方增加(P<0.0001)。APS2阴性的患者中额外脑淀粉样蛋白检测减少(P<0.0001)。这种血液生物标志物检测可以帮助记忆专家指导患者接受抗AD治疗,并排除AD以便进行其他诊断考虑。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/170c/11764142/594de1a87ce4/diagnostics-15-00167-g001.jpg

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