A blood biomarker test for brain amyloid impacts the clinical evaluation of cognitive impairment
Open accessAbstract
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.
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BBMs have not been recommended as standalone diagnostic tests due to a lack of studies demonstrating their equivalence to clinically used CSF and PET methods.
“Despite BBMs being used in clinical practice in some countries, including the United States, they have not been recommended as standalone diagnostic tests due to a lack of studies demonstrating their equivalence to clinically used CSF and PET methods16,35–37.”
From Highly accurate blood test for Alzheimer's disease is similar or superior to clinical cerebrospinal fluid tests (2024) · cites this paper as [37]
The Introduction reports studies comparing a blood biomarker test with amyloid PET, and the Discussion describes its potential to support clinical diagnosis. Neither section states that blood biomarkers are not recommended as standalone diagnostic tests or attributes such a recommendation to a lack of equivalence studies with CSF and PET. Searches for standalone-use recommendations and equivalence found no passage addressing that claim. (LLM, conf=0.74)
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- Authors
- Monane, M., Johnson, K. G., Snider, B. J., Turner, R. S., Drake, J. D., Maraganore, D. M., Bicksel, J. L., Jacobs, D. H., Ortega, J. L., Henderson, J., Jiang, Y., Huang, S., Coppinger, J., Fogelman, I., West, T., & Braunstein, J. B.
- Affiliations
- C2N Diagnostics (United States) (US)
- Duke University (US)
- Washington University in St. Louis (US)
- Georgetown University (US)
- Brown University (US)
- Tulane University (US)
- Capital Neurology Services McLean Virginia USA
- Neurology Services of Orlando Orlando Florida USA
- Stat4ward Pittsburgh Pennsylvania USA
- Corresponding author
- Monane, Mark
- ORCID
- Venue
- Annals of Clinical and Translational Neurology
- Publisher
- Wiley
- Published
- 2023-08-07
- Volume
- 10
- Issue
- 10
- Pages
- 1738-1748
- ISSN
- 2328-9503 (ISSN-L)
- PMC
- PMC10578891
- OpenAlex
- W4385660931
- Cited by
- 32
- References
- 24
- Citations by year
- 2026: 3 · 2025: 17 · 2024: 11 · 2023: 1
- FWCI
- 6.52
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Annals of Clinical and Translational Neurology (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion, cc-by-nc-nd)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- Tulane University
- Georgetown University
- University of South Florida
- NorthShore University HealthSystem
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
- Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cancer-related cognitive impairment studies
- Keywords
- blood biomarkers, amyloid-beta, apolipoprotein E, Alzheimer's disease, cognitive impairment, amyloid PET, clinical utility, patient selection, interpretation of results, clinician survey
- MeSH terms
- Aged, Alzheimer Disease, Amyloid, Brain, Female, Hematologic Tests, Humans, Male, Prospective Studies, Cohort Studies, Biomarkers, Amyloid beta-Peptides, Cognitive Dysfunction
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