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
{"title":"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","authors":"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","doi":"10.1002/acn3.51863","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Objective</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>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.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>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 (<i>p</i> < 0.0001). Anti-AD drug therapy decreased by 46% in low APS patients (<i>p</i> < 0.0001) and increased by 57% in high APS patients (<i>p</i> < 0.0001).</p>\n </section>\n \n <section>\n \n <h3> Interpretation</h3>\n \n <p>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.</p>\n </section>\n </div>","PeriodicalId":126,"journal":{"name":"Annals of Clinical and Translational Neurology","volume":"10 10","pages":"1738-1748"},"PeriodicalIF":4.4000,"publicationDate":"2023-08-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/acn3.51863","citationCount":"1","resultStr":"{\"title\":\"A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment\",\"authors\":\"Mark Monane, Kim G. Johnson, B. Joy Snider, Raymond S. Turner, Jonathan D. Drake, Demetrius M. 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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.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>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 (<i>p</i> < 0.0001). 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A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment
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.
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.
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