Observational studyAlzheimer's research & therapy2026
Prospective study on clinical utility of plasma p-Tau217 and other biomarkers in Japanese memory clinics using the LUMIPULSE platform.
Observational study in Alzheimer's research & therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
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.
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Who cites it
2 citing papers in PubMed.
- Cost analyses of plasma p-tau217 versus p-tau217/Aβ42 ratio using two-step approach in the Japanese health care system.The journal of prevention of Alzheimer's disease · 2026Article
- Clinical utility of LUMIPULSE plasma p-tau217 to identify amyloid positivity among candidates for amyloid-targeting treatments in a real-world cohort.Alzheimer's & dementia (Amsterdam, Netherlands)Article
Corrections and comments
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Authors and funding
24 authors.
Funding
Abstract
backgroundIn recent years, plasma levels of phosphorylated tau species, particularly p-tau217, have emerged as reliable indicators of amyloid-β (Aβ) pathology in the brain. However, real-world data on plasma biomarkers across diverse populations remain limited. We conducted a prospective multicenter study under real-world clinical settings to evaluate diagnostic performance of plasma biomarkers, including p-tau217, in discriminating amyloid status among a Japanese population.
methodsA total of 332 participants were recruited from seven memory clinics across Japan. Participants were categorized into four clinical subgroups: cognitively unimpaired (CU), mild cognitive impairment (MCI), Alzheimer’s disease dementia (ADD), and non-ADD. We measured Aβ40, Aβ42, p-tau181, total-tau, and neurofilament light chain (NfL) in CSF and Aβ40, Aβ42, p-tau217, p-tau181, glial fibrillary acidic protein (GFAP) and NfL in plasma using the LUMIPULSE platform. Amyloid status was determined by amyloid PET imaging and/or CSF Aβ42/40 ratio.
resultsSignificant differences were observed in plasma biomarker levels, including Aβ42/40, p-tau217, p-tau181, GFAP, and NfL across clinical categories. Plasma p-tau217 and p-tau217/Aβ42 achieved high diagnostic accuracy, with areas under the curve (AUC) exceeding 0.9 with PET amyloid status as the reference, demonstrating comparable performance to the in vitro diagnostic (IVD)-approved CSF Aβ42/40 ratio. The two-cutoff approach using plasma p-tau217 and p-tau217/Aβ42 to achieve 90% sensitivity and 90% specificity provided high negative and positive predictive values. The intermediate range defined by these two-cutoff points was narrower for p-tau217/Aβ42 than for p-tau217. The predefined U.S. Food and Drug Administration (FDA)-approved two-cutoff points were applicable to this cohort with good accuracy. Concordance of plasma p-tau217 or p-tau217/Aβ42 with PET or CSF Aβ42/40 status ranged from 87% to 93%, although larger discordant results were observed in the non-ADD group.
conclusionsThis study demonstrates the clinical utility of plasma p-tau217 and p-tau217/Aβ42 ratio for real-world diagnostic evaluations of dementia. However, careful interpretation of plasma biomarker is warranted in cases showing discordant results with PET or CSF findings.
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