Evidence map›Paper›PMID 33688996›Full record

ArticleEuropean journal of nuclear medicine and molecular imaging2021

The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update.

Marina Boccardi, Alessandra Dodich, Emiliano Albanese, Angèle Gayet-Ageron, Cristina Festari, Nicholas J Ashton, Gérard N Bischof, Konstantinos Chiotis, Antoine Leuzy, Emma E Wolters and 11 more

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In one paragraph

Article in European journal of nuclear medicine and molecular imaging, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 28 papers.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed
–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

28 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
  6. Validating plasma biomarkers for distinguishing neurodegenerative and psychiatric disorders.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2026
    Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Personalizing progressive changes to brain structure in Alzheimer's disease using normative modeling.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2024
    Article
  12. Why should academia care about the Target Product Profile?Journal of translational medicine · 2024
    Article
  13. Article
  14. Clinical outcomes up to 9 years after [Alzheimer's research & therapy · 2023
    Article
  15. Personalising Alzheimer's Disease progression using brain atrophy markers.medRxiv : the preprint server for health sciences · 2023
    Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Marina BoccardiGerman Center for Neurodegenerative Diseases DZNE-Standort Rostock/Greifswald, Gehlsheimer Str. 20, 18147, Rostock, Germany. marina.boccardi@dzne.de.ORCID http://orcid.org/0000-0001-6744-8246
Alessandra DodichCenter for Neurocognitive Rehabilitation (CeRiN), CIMeC, University of Trento, Trento, Italy.
Emiliano AlbaneseUSI - Università della Svizzera Italiana, Institute of Public Health (IPH), Lugano, Switzerland.
Angèle Gayet-AgeronDivision of Clinical Epidemiology, Department of Health and Community Medicine, University of Geneva & University Hospitals of Geneva, Geneva, Switzerland.
Cristina FestariLANE - Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Nicholas J AshtonWallenberg Centre for Molecular and Translational Medicine, University of Gothenburg, Gothenburg, Sweden.
Gérard N BischofDepartment of Nuclear Medicine, University Hospital Cologne, Cologne, Germany.
Konstantinos ChiotisDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Antoine LeuzyDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Emma E WoltersAlzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.
Martin A WalterNuclear Medicine and Molecular Division, Geneva Medical Hospital, Geneva, Switzerland.
Gil D RabinoviciDepartments of Neurology, Radiology & Biomedical Imaging, University of California, San Francisco, CA, USA.
Maria CarrilloAlzheimer's Association, Chicago, IL, USA.
Alexander DrzezgaFaculty of Medicine, University of Cologne, Cologne, Germany.
Oskar HanssonClinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden.
Agneta NordbergDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Rik OssenkoppeleAlzheimer Center Amsterdam, Department of Neurology, Amsterdam Neuroscience, Vrije Universiteit Amsterdam, Amsterdam UMC, Amsterdam, Netherlands.
Victor L VillemagneDepartment of Molecular Imaging & Therapy, Austin Health, Melbourne, VIC, Australia.
Bengt WinbladKarolinska University Hospital, Theme Aging, Geriatric Clinic, Huddinge, Sweden.
Giovanni B FrisoniLANVIE - Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland.
Valentina GaribottoNIMTlab - Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.

Funding

Innovative Medicines Initiative 115952Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 320030_169876Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 320030_185028Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung IZSEZ0_188355
6 · The paper itself

Abstract

backgroundThe 2017 Alzheimer's disease (AD) Strategic Biomarker Roadmap (SBR) structured the validation of AD diagnostic biomarkers into 5 phases, systematically assessing analytical validity (Phases 1-2), clinical validity (Phases 3-4), and clinical utility (Phase 5) through primary and secondary Aims. This framework allows to map knowledge gaps and research priorities, accelerating the route towards clinical implementation. Within an initiative aimed to assess the development of biomarkers of tau pathology, we revised this methodology consistently with progress in AD research.

methodsWe critically appraised the adequacy of the 2017 Biomarker Roadmap within current diagnostic frameworks, discussed updates at a workshop convening the Alzheimer's Association and 8 leading AD biomarker research groups, and detailed the methods to allow consistent assessment of aims achievement for tau and other AD diagnostic biomarkers.

resultsThe 2020 update applies to all AD diagnostic biomarkers. In Phases 2-3, we admitted a greater variety of study designs (e.g., cross-sectional in addition to longitudinal) and reference standards (e.g., biomarker confirmation in addition to clinical progression) based on construct (in addition to criterion) validity. We structured a systematic data extraction to enable transparent and formal evidence assessment procedures. Finally, we have clarified issues that need to be addressed to generate data eligible to evidence-to-decision procedures. DISCUSSION: This revision allows for more versatile and precise assessment of existing evidence, keeps up with theoretical developments, and helps clinical researchers in producing evidence suitable for evidence-to-decision procedures. Compliance with this methodology is essential to implement AD biomarkers efficiently in clinical research and diagnostics.

Indexed as

Alzheimer DiseaseCognitive DysfunctionAmyloid beta-PeptidesBiomarkersCross-Sectional StudiesDisease ProgressionHumansReference Standardstau ProteinsAmyloid beta-PeptidesBiomarkerstau ProteinsAlzheimer’s diseaseBiomarkerDementiaMCIMild cognitive impairmentValidation methodology

Identifiers

PMID33688996
PMCPMC8175304

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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.