26 juni 2025: zie enkele artikelen via deze search met zoekwoord Alzheimer op onze website.

26 juni 2025: De FDA - Food and Drug Administration geeft goedkeuring aan het gebruik van de bloedtest Lumipulse G plasma p‐tau217/Aβ42 voor het eventueel vaststellen van de ziekte van Alzheimer in een heel vroeg stadium. De FDA stelt in een persbericht dat de bloedtest minder invasief is, vermindert de afhankelijkheid van petscans en monsters van hersenvocht zijn niet meer nodig.

De Lumipulse G plasma p‐tau217/Aβ42 is bedoeld voor de vroegtijdige ontdekking van amyloïde plaques die verband houden met de ziekte van Alzheimer bij volwassen patiënten van 55 jaar en ouder die tekenen en symptomen van de ziekte vertonen.
De Lumipulse G plasma p‐tau217/Aβ42 meet twee eiwitten, p-tau217 en β-amyloïde 1-42, die voorkomen in menselijk plasma, een onderdeel van bloed, en berekent de numerieke verhouding van de niveaus van de twee eiwitten. Deze verhouding correleert met de aanwezigheid of afwezigheid van amyloïde plaques in de hersenen van de patiënt, waardoor de noodzaak van een PET-scan afneemt. Vergelijkbare door de FDA goedgekeurde/goedgekeurde tests, waarvan er één van hetzelfde bedrijf is als deze nieuwe test, worden gebruikt met monsters van hersenvocht (CSF), die worden verzameld via een invasieve lumbaalpunctie. Deze nieuwe Lumipulse G plasma p‐tau217/Aβ42 bloedtest vereist slechts een eenvoudige bloedafname, waardoor deze minder invasief en veel gemakkelijker toegankelijk is voor patiënten.

De FDA - Food and Drug Administration baseert de goedkeuring op een klinische studie die resulteerde in 91,7% van de personen met een positieve Lumipulse G pTau217/β-amyloïde 1-42 plasmaratio amyloïde plaques op basis van een PET-scan of CSF-test, en 97,3% van de personen met een negatieve uitslag had een negatieve amyloïde PET-scan of CSF-test. Minder dan 20% van de 499 geteste patiënten kreeg een onbepaalde Lumipulse G pTau217/β-amyloïde 1-42 plasmaratio.

Bovenstaande zijn gedeeltes die zijn vertaald uit het persbericht d.d. 16 mei 2025 van de FDA - Food and Drug Administration.

Onderaan het artikel staat het abstract van deze studie:

Diagnostic accuracy of plasma p‐tau217/Aβ42 for Alzheimer's disease in clinical and community cohorts

Lees verder hieronder:

24 januari 2024: Bron: JAMA Neurol. Published online January 22, 2024.

Een eenvoudige bloedtest blijkt tot 96 procent nauwkeurig de ziekte van Alzheimer - dementie te kunnen aantonen door het meten van verhoogde niveaus van beta-amyloid en tot 97 procent bij het identificeren van p-tau217. Deze twee eiwitten veroorzaken de ziekte van Alzheimer - dementie.

De bloedtest kan ook al jaren voordat de ziekte zich manifesteert aantonen dat de ziekte zich gaat voordoen. Verder blijkt de bloedtest een patiëntvriendelijker en goedkoper alternatief voor andere diagnosetechnieken van dementie.

De ziekte van Alzheimer - dementie is een aandoening die naarmate de ziekte erger wordt iemand steeds meer moeite met dagelijkse vaardigheden krijgt en wordt tot nu toe gezien als ongeneeslijk. Wel kan met vooral een gezonde leefstijl de progressie van de ziekte afgeremd worden, zie enkele artikelen via deze search met zoekwoord Alzheimer op onze website.

Uit een recent gepubliceerde studie bleek dat de p-tau217-immunoassay vergelijkbare nauwkeurigheid vertoonde als biomarkers voor hersenvocht bij het identificeren van abnormale amyloïde β (Aβ) en tau-pathologieën.
In drie verschillende onafhankelijk van elkaar uitgevoerde studies voor het detecteren van abnormale Aβ-pathologie waren de resultaten van de bloedtest consistent in alle drie de studiegroepen;
Over een periode van acht jaar vond de grootste verandering in p-tau217 plaats bij individuen die positief waren voor zowel Aβ als tau.

Het originele studierapport is gratis in te zien. Hier het abstract van deze studie:

Key Points

Question What are the capabilities of a commercially available plasma phosphorylated tau 217 (p-tau217) immunoassay to identify Alzheimer disease pathophysiology?

Findings This cohort study found that the p-tau217 immunoassay showed similar accuracies to cerebrospinal fluid biomarkers in identifying abnormal amyloid β (Aβ) and tau pathologies. A 3-range reference for detecting abnormal Aβ pathology was consistent across 3 cohorts; over 8 years, the largest change of p-tau217 was in individuals positive for both Aβ and tau.

Meaning The wider availability of high-performing assays may expedite the use of blood biomarkers in clinical settings and benefit the research community.

Abstract

Importance Phosphorylated tau (p-tau) is a specific blood biomarker for Alzheimer disease (AD) pathology, with p-tau217 considered to have the most utility. However, availability of p-tau217 tests for research and clinical use has been limited. Expanding access to this highly accurate AD biomarker is crucial for wider evaluation and implementation of AD blood tests.

Objective To determine the utility of a novel and commercially available immunoassay for plasma p-tau217 to detect AD pathology and evaluate reference ranges for abnormal amyloid β (Aβ) and longitudinal change across 3 selected cohorts.

Design, Setting, and Participants This cohort study examined data from 3 single-center observational cohorts: cross-sectional and longitudinal data from the Translational Biomarkers in Aging and Dementia (TRIAD) cohort (visits October 2017–August 2021) and Wisconsin Registry for Alzheimer’s Prevention (WRAP) cohort (visits February 2007–November 2020) and cross-sectional data from the Sant Pau Initiative on Neurodegeneration (SPIN) cohort (baseline visits March 2009–November 2021). Participants included individuals with and without cognitive impairment grouped by amyloid and tau (AT) status using PET or CSF biomarkers. Data were analyzed from February to June 2023.

Exposures Magnetic resonance imaging, Aβ positron emission tomography (PET), tau PET, cerebrospinal fluid (CSF) biomarkers (Aβ42/40 and p-tau immunoassays), and plasma p-tau217 (ALZpath pTau217 assay).

Main Outcomes and Measures Accuracy of plasma p-tau217 in detecting abnormal amyloid and tau pathology, longitudinal p-tau217 change according to baseline pathology status.

Results The study included 786 participants (mean age, 66.3 [9.7] years; 504 females [64.1%] and 282 males [35.9%]). High accuracy was observed in identifying elevated Aβ (area under the curve , 0.92-0.96; 95% CI, 0.89-0.99) and tau pathology (AUC, 0.93-0.97; 95% CI, 0.84-0.99) across all cohorts. These accuracies were comparable with CSF biomarkers in determining abnormal PET signal. The detection of abnormal Aβ pathology using a 3-range reference yielded reproducible results and reduced confirmatory testing by approximately 80%. Longitudinally, plasma p-tau217 values showed an annual increase only in Aβ-positive individuals, with the highest increase observed in those with tau positivity.

Conclusions and Relevance This study found that a commercially available plasma p-tau217 immunoassay accurately identified biological AD, comparable with results using CSF biomarkers, with reproducible cut-offs across cohorts. It detected longitudinal changes, including at the preclinical stage.

Article Information

Accepted for Publication: November 10, 2023.

Published Online: January 22, 2024. doi:10.1001/jamaneurol.2023.5319

Corresponding Author: Nicholas J. Ashton, PhD, Institute of Neuroscience and Physiology, Department of Psychiatry and Neurochemistry, Sahlgrenska Academy at Gothenburg University, Mölndal Hospital, Hus V3, 43180 Mölndal, Sweden (nicholas.ashton@gu.se).

Author Contributions: Dr Ashton had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. Dr Ashton and Mr Brum contributed equally as co–first authors.

Concept and design: Ashton, Brum, Benedet, Vanmechelen, Montoliu-Gaya, Servaes, Therriault, Pascoal, Johnson, Blennow, Zetterberg.

Acquisition, analysis, or interpretation of data: Ashton, Brum, Di Molfetta, Benedet, Arslan, Jonaitis, Langhough, Cody, Wilson, Carlsson, Montoliu-Gaya, Lantero-Rodriguez, Rahmouni, Tissot, Stevenson, Therriault, Pascoal, Lleó, Alcolea, Fortea, Rosa-Neto, Johnson, Jeromin, Blennow, Zetterberg.

Drafting of the manuscript: Ashton, Brum, Arslan, Johnson.

Critical review of the manuscript for important intellectual content: Ashton, Brum, Di Molfetta, Benedet, Jonaitis, Langhough, Cody, Wilson, Carlsson, Vanmechelen, Montoliu-Gaya, Lantero-Rodriguez, Rahmouni, Tissot, Stevenson, Servaes, Therriault, Pascoal, Lleó, Alcolea, Fortea, Rosa-Neto, Johnson, Jeromin, Blennow, Zetterberg.

Statistical analysis: Ashton, Brum, Jonaitis, Therriault.

Obtained funding: Tissot, Fortea, Rosa-Neto, Johnson, Zetterberg.

Administrative, technical, or material support: Ashton, Benedet, Jonaitis, Cody, Wilson, Carlsson, Vanmechelen, Montoliu-Gaya, Rahmouni, Tissot, Stevenson, Servaes, Therriault, Lleó, Fortea, Rosa-Neto, Jeromin, Zetterberg.

Supervision: Ashton, Fortea, Blennow.

Additional Contributions: We thank Jeroen Vanbrabant, PhD, and Erik Stoops, PhD, from ADx Neuroscience, now Fujirebio, and the accelerator lab at Quanterix, for the initial prototyping of the ALZpath pTau217 assay.

Plasma p‐tau217/Aβ42 has high performance in detecting cerebral AD pathologies, thus offering a promising tool for clinical diagnosis and community screening of AD.

. 2025 Mar 29;21(3):e70038. doi: 10.1002/alz.70038

Diagnostic accuracy of plasma p‐tau217/Aβ42 for Alzheimer's disease in clinical and community cohorts

Jun Wang ^1,², Shan Huang ^1,², Guoyu Lan ³, Yu‐Jie Lai ^1,², Qing‐Hua Wang ^1,², Yang Chen ^1,², Zhong‐Song Xiao ⁴, Xiao Chen ⁵, Xian‐Le Bu ^1,², Yu‐Hui Liu ^1,², Fan Zeng ^1,², Laihong Zhang ³, Anqi Li ³, Yue Cai ³, Pan Sun ³, Zhengbo He ³, Vincent Doré ^6,⁷, Jurgen Fripp ⁶, Pierrick Bourgeat ⁶, Qin Chen ⁸, Jin‐Tai Yu ⁹, Yi Tang ¹⁰, Henrik Zetterberg ^11,^12,^13,^14,^15,¹⁶, Colin L Masters ¹⁷, Tengfei Guo ^3,^✉, Yan‐Jiang Wang ^1,^2,^4,^✉; for the Translational Biomarker Research of AgIng and Neurodegeneration (TBRAIN)

PMCID: PMC11953589 PMID: 40156286

Abstract

INTRODUCTION

This study was undertaken to evaluate the diagnostic performance of a novel plasma phosphorylated tau (p‐tau) 217/amyloid beta (Aβ) 42 ratio test for Alzheimer's disease (AD).

METHODS

The diagnostic performance of the Lumipulse G plasma p‐tau217/Aβ42 ratio was evaluated using Aβ and tau positron emission tomography (PET) as reference standards in a clinic cohort (n = 391) and a community cohort (n = 121).

RESULTS

Plasma p‐tau217/Aβ42 exhibited high performance for abnormal statuses of Aβ PET (area under the curve : 0.963 to 0.966) and tau PET (AUC: 0.947 to 0.974), which were clinically equivalent to those of cerebrospinal fluid (CSF) p‐tau181/Aβ42 and Aβ42/Aβ40 and higher than those of blood p‐tau217, Aβ42/Aβ40, p‐tau181, and p‐tau181/Aβ42 in both clinic and community cohorts. Applying a two‐cutoff approach improved the specificity without reducing sensitivity. The p‐tau217/Aβ42 ratio had a lower intermediate percentage than p‐tau217 alone in both clinic (10.6% vs 13.0%) and community (16.5% vs 31.4%) cohorts.

DISCUSSION

Plasma p‐tau217/Aβ42 has high performance in detecting cerebral AD pathologies, thus offering a promising tool for clinical diagnosis and community screening of AD.

Highlights

Lumipulse G plasma p‐tau217 and the p‐tau217/Aβ42 ratio accurately identified abnormal Aβ and tau PET statuses in both clinical and community cohorts.
The performance of plasma p‐tau217 and p‐tau217/Aβ42 ratio were equivalent to CSF tests.
Plasma p‐tau217/Aβ42 ratio outperformed p‐tau217 alone in identifying Aβ PET positivity, and this superiority is more obvious in the community cohort, suggesting an advantage in the early diagnosis of AD.
Two cut points of p‐tau217/Aβ42 were established in the Chinese population for clinical laboratory and community screening uses.

ACKNOWLEDGMENTS

The study was supported by the National Key Research and Development Program of China (2023YFC3605400 to Y.‐J. W.), the National Natural Science Foundation of China (92249305 and 81930028 to Y.‐J. W., 82422027 and 82171197 to T.F. G.), joint project of the Chongqing Science and Technology Bureau and the Health Commission (2024GGXM003 to Y.‐J.W.), Guangdong Basic and Applied Basic Science Foundation (2023B1515020113 to T.F.G.), and Shenzhen Bay Laboratory (S241101004‐1 to T.F. G.). H.Z. is a Wallenberg Scholar and a Distinguished Professor at the Swedish Research Council supported by grants from the Swedish Research Council (2023‐00356; 2022‐01018, and 2019‐02397), the European Union's Horizon Europe Research and Innovation Programme under Grant Agreement 101053962, and Swedish State Support for Clinical Research (ALFGBG‐71320). We thank all the research volunteers who participated in CADS and GHABS studies from which these data were obtained and their supportive families. We also thank Sen Liu, Hong Zhang, and Zhao‐Xue Zhang from Beijing Pason Pharmaceuticals Inc. for the technical support. PET imaging data used in the preparation of this article were obtained from the Australian Imaging, Biomarker and Lifestyle (AIBL) Study database (https://aibl.org.au/collaboration/#data‐access). As such, the investigators within AIBL contributed to the design and implementation of AIBL and/or provided data but did not participate in the analysis or writing of this report. A complete listing of AIBL investigators can be found at: https://aibl.org.au/about/our‐researchers/. The corresponding author had full access to all data in the study, and all authors had final responsibility for the decision to submit for publication.

Wang J, Huang S, Lan G, et al.,; for the Translational Biomarker Research of AgIng ,; Neurodegeneration (TBRAIN) . Diagnostic accuracy of plasma p‐tau217/Aβ42 for Alzheimer's disease in clinical and community cohorts. Alzheimer's Dement. 2025;21:e70038. 10.1002/alz.70038

Jun Wang, Shan Huang, Guoyu Lan, and Yu‐Jie Lai contributed equally to this study.

Contributor Information

Tengfei Guo, Email: tengfei.guo@pku.edu.cn.

Yan‐Jiang Wang, Email: yanjiang_wang@tmmu.edu.cn.

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