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- Title
A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment.
- Authors
Monane, Mark; Johnson, Kim G.; Snider, B. Joy; Turner, Raymond S.; Drake, Jonathan D.; Maraganore, Demetrius M.; Bicksel, James L.; Jacobs, Daniel H.; Ortega, Julia L.; Henderson, Joni; Jiang, Yan; Huang, Shuguang; Coppinger, Justine; Fogelman, Ilana; West, Tim; Braunstein, Joel B.
- 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.
- Subjects
BLOOD testing; AMYLOID; COGNITION disorders; CEREBRAL amyloid angiopathy; POSITRON emission tomography; ALZHEIMER'S patients; MILD cognitive impairment
- Publication
Annals of Clinical & Translational Neurology, 2023, Vol 10, Issue 10, p1738
- ISSN
2328-9503
- Publication type
Article
- DOI
10.1002/acn3.51863