Evidence map›Paper›PMID 39030981›Full record

ArticleAlzheimer's & dementia : the journal of the Alzheimer's Association2024

Optimizing cutpoints for clinical interpretation of brain amyloid status using plasma p-tau217 immunoassays.

Daniel J Figdore, Michael Griswold, Joshua A Bornhorst, Jonathan Graff-Radford, Vijay K Ramanan, Prashanthi Vemuri, Val J Lowe, David S Knopman, Clifford R Jack, Ronald C Petersen and 1 more

Abstract read
In one paragraph

Article in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 66 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Diagnostic accuracy of plasma p-tau217 against amyloid PET: A meta-analysis of technical platform variability and ratio versus single marker comparisons.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026
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6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Daniel J FigdoreDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
Michael GriswoldThe MIND Center, University of Mississippi Medical Center, Jackson, Mississippi, USA.
Joshua A BornhorstDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.
Jonathan Graff-RadfordDepartment of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
Vijay K RamananDepartment of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
Prashanthi VemuriDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
Val J LoweDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
David S KnopmanDepartment of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
Clifford R JackDepartment of Radiology, Mayo Clinic, Rochester, Minnesota, USA.
Ronald C PetersenDepartment of Neurology, Mayo Clinic, Rochester, Minnesota, USA.
Alicia Algeciras-SchimnichDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota, USA.ORCID 0000-0002-4455-6217

Funding

SUPPLEMENT TO ALZHEIMERS DISEASE PATIENT REGISTRYU01AG006786 · NIA · MAYO CLINIC ROCHESTER · PI GRAFF-RADFORD, JONATHAN, JACK, CLIFFORD R. · 1986 to 2023
$49.6M
Research Education ComponentP30AG062677 · NIA · MAYO CLINIC ROCHESTER · PI NILUFER ERTEKIN-TANER · 2019 to 2026
$33.5M
Investigating Resistance and Resilience Mechanisms in Alzheimer’s DiseaseR01AG056366 · NIA · MAYO CLINIC ROCHESTER · PI PRASHANTHI VEMURI · 2017 to 2026
$7.0M
Blood amyloid-beta relationship with amyloid plaques and CSF amyloid-betaRF1AG061900 · NIA · WASHINGTON UNIVERSITY · PI BATEMAN, RANDALL J · 2019 to 2020
$6.9M
Disease pathways in the population determined by amyloid, tau, and neurodegeneration imaging biomarkersR37AG011378 · NIA · MAYO CLINIC ROCHESTER · PI CLIFFORD R. JACK · 2018 to 2026
$6.8M
Validating the New Criteria for Preclinical Alzheimer's diseaseR01AG041851 · NIA · MAYO CLINIC ROCHESTER · PI JACK, CLIFFORD R., KNOPMAN, DAVID S · 2012 to 2021
$6.3M
"What is N?" Towards operationalizing neurodegeneration in Alzheimer's and related dementiasRF1AG069052 · NIA · MAYO CLINIC ROCHESTER · PI GRAFF-RADFORD, JONATHAN, MIELKE, MICHELLE M · 2021 to 2021
$2.4M
NIA NIH HHS P30 AG062677NIA NIH HHS R01 AG041851NIA NIH HHS R01 AG056366NIA NIH HHS R37 AG011378NIA NIH HHS RF1 AG061900NIA NIH HHS RF1 AG069052NIA NIH HHS U01 AG006786NIH HHS P30 AG062677
6 · The paper itself

Abstract

introductionWe aimed to evaluate clinical interpretation cutpoints for two plasma phosphorylated tau (p-tau)217 assays (ALZpath and Lumipulse) as predictors of amyloid status for implementation in clinical practice.

methodsClinical performance of plasma p-tau217 against amyloid positron emission tomography status was evaluated in participants with mild cognitive impairment or mild dementia (n = 427).

resultsUsing a one-cutpoint approach (negative/positive), neither assay achieved ≥ 90% in both sensitivity and specificity. A two-cutpoint approach yielding 92% sensitivity and 96% specificity provided the desired balance of false positives and false negatives, while categorizing 20% and 39% of results as indeterminate for the Lumipulse and ALZpath assays, respectively. DISCUSSION: This study provides a systematic framework for selection of assay-specific cutpoints for clinical use of plasma p-tau217 for determination of amyloid status. Our findings suggest that a two-cutpoint approach may have advantages in optimizing diagnostic accuracy while minimizing potential harm from false positive results. HIGHLIGHTS: Phosphorylated tau (p-tau)217 cutpoints for detection of amyloid pathology were established. A two-cutpoint approach exhibited the best performance for clinical laboratory use. p-tau217 assays differed in the percentage of results categorized as intermediate.

Indexed as

BrainCognitive DysfunctionPositron-Emission Tomographytau ProteinsAgedAged, 80 and overBiomarkersFemaleHumansImmunoassayMalePhosphorylationSensitivity and SpecificityBiomarkerstau ProteinsAlzheimer's diseaseamyloid pathologyamyloid positron emission tomographyblood‐based biomarkerscutpointsFujirebio Lumipulseimmunoassaysplasma phosphorylated tau217Simoa ALZpath

Identifiers

PMID39030981
PMCPMC11497693

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.