Evidence map›Paper›PMID 38866966›Full record

ReviewNature reviews. Neurology2024

Acceptable performance of blood biomarker tests of amyloid pathology - recommendations from the Global CEO Initiative on Alzheimer's Disease.

Suzanne E Schindler, Douglas Galasko, Ana C Pereira, Gil D Rabinovici, Stephen Salloway, Marc Suárez-Calvet, Ara S Khachaturian, Michelle M Mielke, Chi Udeh-Momoh, Joan Weiss and 25 more

Registry-linked trialAbstract readReview
PubMed Publisher
In one paragraph

Review in Nature reviews. Neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06856681 (A Study of the Clinical Effect of the Implementation of a Blood Biomarker Into Memory Clinics in the Department of Veterans Affairs and Other Closed System Healthcare Memory and Dementia Sites in the United States), which is not on this map. Cited by 212 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
212citing papers in PubMed, 8 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.

NCT06856681 nawithdrawnnot on this mapstarted 2025, after this paper: background citation

A Study of the Clinical Effect of the Implementation of a Blood Biomarker Into Memory Clinics in the Department of Veterans Affairs and Other Closed System Healthcare Memory and Dementia Sites in the United States

TypeinterventionalSponsorC2N DiagnosticsRan2025 to 2028Enrolled0ConditionsAlzheimers DiseaseArmsPrecivityAD2 - Early Testing, PrecivityAD2 - Delayed Testing
3 · Its place in the literature

Who cites it

212 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Cost-effectiveness of testing biofluid biomarkers to diagnose Alzheimer's disease: a systematic review.The European journal of health economics : HEPAC : health economics in prevention and care · 2026
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Guideline
  9. Plasma P-tau217 for detecting amyloid clearance after donanemab in Alzheimer's disease.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Trial
  10. Trial
  11. Article
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. More efficient screening for preclinical Alzheimer's clinical trials using mixture of experts.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Review
  18. Review
  19. Article
  20. Article

152 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

35 authors.

Suzanne E SchindlerDepartment of Neurology, Knight Alzheimer's Disease Research Center, Washington University School of Medicine, St Louis, MO, USA. schindler.s.e@wustl.edu.ORCID 0000-0002-1680-1465
Douglas GalaskoDepartment of Neurosciences, University of California, San Diego, La Jolla, CA, USA.
Ana C PereiraDepartment of Neurology, Icahn School of Medicine, Mount Sinai, New York, NY, USA.
Gil D RabinoviciDepartment of Neurology, Weill Institute for Neurosciences, University of California, San Francisco, CA, USA.
Stephen SallowayDepartment of Neurology, Alpert Medical School, Brown University, Providence, RI, USA.
Marc Suárez-CalvetBarcelonaβeta Brain Research Center, Pasqual Maragall Foundation, Barcelona, Spain.ORCID 0000-0002-2993-569X
Ara S KhachaturianThe Campaign to Prevent Alzheimer's Disease, Rockville, MD, USA.ORCID 0000-0001-9973-5039
Michelle M MielkeDepartment of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA.ORCID 0000-0001-7177-1185
Chi Udeh-MomohDepartment of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, NC, USA.
Joan WeissUS Department of Health and Human Services, Health Resources and Services Administration, Bureau of Health Workforce, Rockville, MD, USA.
Richard BatrlaEisai Inc., Nutley, NJ, USA.
Sasha BozeatF. Hoffman-La Roche AG, Basel, Switzerland.
John R DwyerGlobal Alzheimer's Platform Foundation, Washington, DC, USA.
Drew HolzapfelThe Global CEO Initiative on Alzheimer's Disease, Philadelphia, PA, USA.
Daryl Rhys JonesEisai Inc., Nutley, NJ, USA.
James F MurrayDavos Alzheimer's Collaborative, Philadelphia, PA, USA.
Katherine A PartrickThe Global CEO Initiative on Alzheimer's Disease, Philadelphia, PA, USA.
Emily SchollerThe Global CEO Initiative on Alzheimer's Disease, Philadelphia, PA, USA.
George VradenburgDavos Alzheimer's Collaborative, Philadelphia, PA, USA.
Dylan YoungGuidehouse, McLean, VA, USA.
Alicia Algeciras-SchimnichDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.
Jiri AubrechtProthena Biosciences Inc., Brisbane, CA, USA.
Joel B BraunsteinC2N Diagnostics, St Louis, MO, USA.
James HendrixEli Lilly and Company, Indianapolis, IN, USA.
Yan Helen HuEisai Inc., Nutley, NJ, USA.ORCID 0000-0003-3269-4505
Soeren MattkeThe USC Brain Health Observatory, University of Southern California, Los Angeles, CA, USA.ORCID 0000-0003-4666-9132
Mark MonaneC2N Diagnostics, St Louis, MO, USA.
David ReillyGuidehouse, McLean, VA, USA.
Elizabeth SomersEisai Inc., Nutley, NJ, USA.
Charlotte E TeunissenNeurochemistry Laboratory, Department of Clinical Chemistry, Amsterdam Neuroscience, Amsterdam University Medical Centers, Vrije Universitiet, Amsterdam, The Netherlands.
Eli ShobinBiogen, Cambridge, MA, USA.
Hugo VandersticheleBiomarkable BV, Gent, Belgium.
Michael W WeinerDepartment of Radiology and Biomedical Imaging, University of California, San Francisco, CA, USA.
David WilsonQuanterix Corporation, Billerica, MA, USA.
Oskar HanssonClinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden. oskar.hansson@med.lu.se.ORCID 0000-0001-8467-7286

Funding

Staging Alzheimer disease with blood-based biomarkersR01AG070941 · NIA · WASHINGTON UNIVERSITY · PI SCHINDLER, SUZANNE ELIZABETH · 2021 to 2025
$4.3M
Policy options to improve access to memory care for disadvantaged individuals who are dually eligible for Medicare and MedicaidR01AG083189 · NIA · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Soeren Mattke · 2023 to 2026
$2.3M
NIA NIH HHS R01 AG070941NIA NIH HHS R01 AG083189
6 · The paper itself

Abstract

Anti-amyloid treatments for early symptomatic Alzheimer disease have recently become clinically available in some countries, which has greatly increased the need for biomarker confirmation of amyloid pathology. Blood biomarker (BBM) tests for amyloid pathology are more acceptable, accessible and scalable than amyloid PET or cerebrospinal fluid (CSF) tests, but have highly variable levels of performance. The Global CEO Initiative on Alzheimer's Disease convened a BBM Workgroup to consider the minimum acceptable performance of BBM tests for clinical use. Amyloid PET status was identified as the reference standard. For use as a triaging test before subsequent confirmatory tests such as amyloid PET or CSF tests, the BBM Workgroup recommends that a BBM test has a sensitivity of ≥90% with a specificity of ≥85% in primary care and ≥75-85% in secondary care depending on the availability of follow-up testing. For use as a confirmatory test without follow-up tests, a BBM test should have performance equivalent to that of CSF tests - a sensitivity and specificity of ~90%. Importantly, the predictive values of all biomarker tests vary according to the pre-test probability of amyloid pathology and must be interpreted in the complete clinical context. Use of BBM tests that meet these performance standards could enable more people to receive an accurate and timely Alzheimer disease diagnosis and potentially benefit from new treatments.

Indexed as

Alzheimer DiseaseBiomarkersAmyloid beta-PeptidesHumansPositron-Emission TomographyAmyloid beta-PeptidesBiomarkers

Identifiers

PMID38866966

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

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.