Evidence map›Paper›PMID 41711262›Full record

ArticleAlzheimer's & dementia : the journal of the Alzheimer's Association2026

The Alzheimer's Disease Diagnosis and Plasma Phospho-Tau217 (ADAPT) study stage 1: Validating clinical cut-points against CSF and amyloid PET.

Ashvini Keshavan, Katharine Wiltshire, Ryan Wee, Irene Gorostiaga Belio, Katie Tucker, Melanie Hart, Michael P Lunn, Michael C B David, Laura Rizzo, Omid Sadeghi-Alavijeh and 7 more

Abstract readValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Alzheimer's & dementia : the journal of the Alzheimer's Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

17 authors.

Ashvini KeshavanDementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.ORCID 0000-0003-1043-5721
Katharine WiltshireDementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.ORCID 0009-0006-0576-7819
Ryan WeeKing's College Hospital NHS Foundation Trust, London, UK.
Irene Gorostiaga BelioDementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.
Katie TuckerDementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.
Melanie HartNeuroimmunology & CSF Laboratory, National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust (UCLH) Queen Square London, London, UK.
Michael P LunnNeuroimmunology & CSF Laboratory, National Hospital for Neurology and Neurosurgery, University College London Hospitals NHS Foundation Trust (UCLH) Queen Square London, London, UK.
Michael C B DavidUK Dementia Research Institute Centre for Care Research and Technology, London, UK.
Laura RizzoUK Dementia Research Institute Centre for Care Research and Technology, London, UK.
Omid Sadeghi-AlavijehUCL Department of Renal Medicine, University College London, London, UK.
Patricia WilsonUCL Department of Renal Medicine, University College London, London, UK.
Daniel P GaleUCL Department of Renal Medicine, University College London, London, UK.
Amanda J HeslegraveUK Dementia Research Institute at UCL, University College London, London, UK.
Henrik ZetterbergUK Dementia Research Institute at UCL, University College London, London, UK.
Nick C FoxDementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.
Paresh MalhotraUK Dementia Research Institute Centre for Care Research and Technology, London, UK.
Jonathan M SchottDementia Research Centre, UCL Queen Square Institute of Neurology, London, UK.

Funding

Blood Biomarker Challenge ARUK-BBC2023-002
6 · The paper itself

Abstract

introductionWe validated plasma phosphorylated tau (p-tau)217 cut-points for Alzheimer's disease (AD) diagnosis using two commercial assays in two biomarker-defined cohorts and examined influences of pre-analytical factors and chronic kidney disease (CKD) on p-tau217 concentrations.

methodsLumipulse (Fujirebio) and ALZpath (Quanterix) assays quantified plasma p-tau217 in symptomatic patients (AD status definition cerebrospinal fluid [CSF] n = 257; amyloid positron emission tomography [PET] n = 76). Receiver operating characteristic (ROC) analyses established ≥ 95% sensitivity/specificity cut-points. In separate cohorts we evaluated the impact of pre-analytical handling/transport variations (n = 40/10) and cognitively normal (CN)-CKD individuals (n = 58).

resultsDiagnostic accuracy was similar (area under the ROC Lumipulse 0.947; ALZpath 0.940). Lumipulse p-tau217 achieved 95% sensitivity and 97% specificity using dual cut-points (0.153/0.422 pg/mL), producing indeterminate results in 19.4% (CSF defined) and 34.2% (PET defined). P-tau217 concentrations were stable across handling conditions and kit lots, and mostly in the low-to-intermediate range in CN-CKD. DISCUSSION: Lumipulse plasma p-tau217, now available in our United Kingdom Accreditation Service-accredited clinical National Health Service laboratory, will be used in a randomized trial of p-tau217 result disclosure in memory services.

Indexed as

Alzheimer DiseasePositron-Emission Tomographytau ProteinsAgedAged, 80 and overAmyloid beta-PeptidesBiomarkersFemaleHumansMaleMiddle AgedPhosphorylationROC CurveSensitivity and SpecificityAmyloid beta-PeptidesBiomarkersMAPT protein, humantau ProteinsAlzheimer's diseaseblood‐based biomarkerscerebrospinal fluidchronic kidney diseasecut‐pointsFujirebio Lumipulsephosphorylated tau217phospho‐tauplasma biomarkerspositron emission tomographypreanalyticsSimoa ALZpath

Identifiers

PMID41711262
PMCPMC12917852

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Registered trials

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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.