Evidence map›Paper›PMID 33590274›Full record

ReviewEuropean journal of nuclear medicine and molecular imaging2021

Clinical validity of second-generation tau PET tracers as biomarkers for Alzheimer's disease in the context of a structured 5-phase development framework.

Gérard N Bischof, Alessandra Dodich, Marina Boccardi, Thilo van Eimeren, Cristina Festari, Henryk Barthel, Oskar Hansson, Agneta Nordberg, Rik Ossenkoppele, Osama Sabri and 3 more

Abstract readReview
In one paragraph

Review 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. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 citing papers in PubMed.

  1. Review
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  6. Test-retest performance of [Imaging neuroscience (Cambridge, Mass.) · 2024
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  14. Brain Trauma Imaging.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2023
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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

13 authors.

Gérard N BischofDepartment of Nuclear Medicine, University Hospital Cologne, Cologne, Germany. gerard.bischof@uk-koeln.de.ORCID http://orcid.org/0000-0002-4366-5171
Alessandra DodichNIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.
Marina BoccardiGerman Center for Neurodegenerative Disorders (DZNE), Rostock/Greifswald, Rostock, Germany.
Thilo van EimerenDepartment of Nuclear Medicine, University Hospital Cologne, Cologne, Germany.
Cristina FestariLANE - Laboratory of Alzheimer's Neuroimaging and Epidemiology, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.
Henryk BarthelDepartment of Nuclear Medicine, University of Leipzig, Leipzig, Germany.
Oskar HanssonMemory Clinic, Skåne University Hopsital, Malmö, Sweden.
Agneta NordbergDivision of Clinical Geriatrics, Center for Alzheimer Research, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
Rik OssenkoppeleClinical Memory Research Unit, Department of Clinical Sciences Malmö, Lund University, Lund, Sweden.
Osama SabriDepartment of Nuclear Medicine, University of Leipzig, Leipzig, Germany.
B Frisoni G GiovanniNIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.
Valentina GaribottoNIMTlab, Neuroimaging and Innovative Molecular Tracers Laboratory, University of Geneva, Geneva, Switzerland.
Alexander DrzezgaDepartment of Nuclear Medicine, University Hospital Cologne, Cologne, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn 2017, the Geneva Alzheimer's disease (AD) strategic biomarker roadmap initiative proposed a framework of the systematic validation AD biomarkers to harmonize and accelerate their development and implementation in clinical practice. Here, we use this framework to examine the translatability of the second-generation tau PET tracers into the clinical context.

methodsAll available literature was systematically searched based on a set of search terms that related independently to analytic validity (phases 1-2), clinical validity (phase 3-4), and clinical utility (phase 5). The progress on each of the phases was determined based on scientific criteria applied for each phase and coded as fully, partially, preliminary achieved or not achieved at all.

resultsThe validation of the second-generation tau PET tracers has successfully passed the analytical phase 1 of the strategic biomarker roadmap. Assay definition studies showed evidence on the superiority over first-generation tau PET tracers in terms of off-target binding. Studies have partially achieved the primary aim of the analytical validity stage (phase 2), and preliminary evidence has been provided for the assessment of covariates on PET signal retention. Studies investigating of the clinical validity in phases 3, 4, and 5 are still underway.

conclusionThe current literature provides overall preliminary evidence on the establishment of the second-generation tau PET tracers into the clinical context, thereby successfully addressing some methodological issues from the tau PET tracer of the first generation. Nevertheless, bigger cohort studies, longitudinal follow-up, and examination of diverse disease population are still needed to gauge their clinical validity.

Indexed as

Alzheimer DiseaseBiomarkersCohort StudiesHumansPositron-Emission Tomographytau ProteinsBiomarkerstau ProteinsAlzheimer’s diseaseBiomarker-based diagnosisSecond-generation tau PET tracersStrategic roadmap

Identifiers

PMID33590274
PMCPMC8175320

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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.