Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jan 13;15(2):167.
doi: 10.3390/diagnostics15020167.

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

Mark Monane  1 , Demetrius M Maraganore  2 , Robert M Carlile  3 , Kim G Johnson  4 , David A Merrill  5 , Darren R Gitelman  6 , Kenneth S Sharlin  7 , Lawren A VandeVrede  8 , Kristi K George  9 , Jimin Wang  10 , Tim West  1 , Leslie Jacobs  1 , Philip B Verghese  1 , Joel B Braunstein  1
Affiliations

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

Mark Monane et al. Diagnostics (Basel). .

Abstract

Objective: 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. Methods: 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. Results: 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% (p < 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 (p < 0.0001). Additional brain amyloid testing decreased among negative APS2 patients (p < 0.0001). Conclusions: 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.

Keywords: Alzheimer’s disease; blood biomarker; clinical decision-making; clinical utility; dementia; diagnosis; memory care specialists; mild cognitive impairment.

PubMed Disclaimer

Conflict of interest statement

Matt Carlile has received Speakers Bureau payments from AbbVie, Lilly, and Teva. Kristi George has received clinical trial support from AbbVie, Annovis, Biogen, and Lilly. Darren Gitelman has received grants or contracts from AbbVie, the Alzheimer’s Association, Biogen, Bristol Myers Squibb, Cassava, Davos Alzheimer’s Collaborative, Eisai, and Lilly. He has received consulting fees from AbbVie, Eisai, Genentech/Roche, Nutricia, Novo Nordisk, and WIRB—Copernicus. Kim Johnson, has received research funding from the Alzheimer’s Association, Athira, Annovis, Eisai, LEXEO Pharmaceuticals, and The Clinical Path Institute. She has received consulting fees from Lilly and the University of Southern California. She has received payment or honoraria from Eisai and PeerView. Kenneth Sharlin has received honoraria from Lilly, Biogen, Sanofi, Pfizer, AbbVie, Immunic, and Ari Bio. Lawren VandeVrede, has received research support from the Alzheimer’s Association Clinician Fellowship Award, the National Institute of Aging, and the Shenandoah Foundation. He has received support for attending meetings and/or travel from the Alzheimer’s Association. Jimin Wang is an employee of Stat4Ward and has received consulting fees from C2N Diagnostics, LLC. Joel Braunstein (MD, MBA), Leslie Jacobs, Mark Monane, Philip Verghese, and Tim West are salaried employees or consultants with equity interests in C2N Diagnostics, LLC. Demetrius Maraganore and David Merrill have no competing interests. C2N Diagnostics, LLC provided study implementation and management support and assisted with drafting and critical review of the manuscript.

Figures

Figure 1
Figure 1
CONSORT/STROBE diagram with patient blood sample and clinician survey flow. Legend for Figure 1: A total of 213 patient blood samples were received, and 10/213 (6%) were not evaluable. A total of 203 patients were included in the final analysis: 200/203 (99%) patients met the intended use criteria for the test. Clinicians completed 203/203 (100%) surveys matched to these patient blood samples.
Figure 2
Figure 2
Change in distribution of the clinician-reported probability of Alzheimer’s disease (AD) pre- and post-BBM testing. Legend for Figure 2: Clinician-reported probability of disease is reported in percentage. Pre-test probability (figure on left) was derived from the clinician survey to reflect the probability of AD before BBM testing. Post-BBM test probability (figure on the right) was derived from the clinician survey to reflect the probability of AD after BBM testing. Data were analyzed using the Kolmogorov–Smirnov (KS) Test. The p-value is less than 0.001, indicating that the distributions of AD probability (pre- and post-BBM test) are significantly different, suggesting that the two groups yield different results.
See this image and copyright information in PMC

References

    1. FRED Federal Reserve Bank of St. Louis. 2024. [(accessed on 19 November 2024)]. Available online: https://fred.stlouisfed.org/series/LNU00024230.
    1. Spargo D., Zur R., Lin P.J., Synnott P., Klein E., Hartry A. Estimating prevalence of early symptomatic Alzheimer’s disease in the United States. Alzheimers Dement. 2023;15:e12497. doi: 10.1002/dad2.12497. - DOI - PMC - PubMed
    1. Knopman D.S., Petersen R.C. Mild cognitive impairment and mild dementia: A clinical perspective. Mayo Clin. Proc. 2014;89:1452–1459. doi: 10.1016/j.mayocp.2014.06.019. - DOI - PMC - PubMed
    1. Rajan K.B., Weuve J., Barnes L.L., McAninch E.A., Wilson R.S., Evans D.A. Population estimate of people with clinical Alzheimer’s disease and mild cognitive impairment in the United States (2020–2060) Alzheimers Dement. 2021;17:1966–1975. doi: 10.1002/alz.12362. - DOI - PMC - PubMed
    1. Alzheimer’s Association 2023 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dement. 2023;19:1598–1695. doi: 10.1002/alz.13016. - DOI - PubMed