Clinical utility of LUMIPULSE plasma p‐tau217 to identify amyloid positivity among candidates for amyloid‐targeting treatments in a real‐world cohort
Ryosuke Shimasaki, Masanori Kurihara, Kenichiro Sato, Taro Bannai, Keiko Hatano, Kenji Ishii, Ryoko Ihara, Sumito Ogawa, Atsushi IwataAbstract
INTRODUCTION
Increasing clinical use of amyloid‐targeting treatments (ATTs) requires accessible biomarkers for Alzheimer's disease (AD). Although the utility of plasma phosphorylated tau 217 (p‐tau217) is well established in research cohorts and its use for identifying amyloid positivity among ATT candidates is expanding into clinical practice, real‐world evidence of its performance is lacking.
METHODS
We evaluated the utility of LUMIPULSE plasma p‐tau217 in a real‐world cohort of 99 patients screened for ATT eligibility.
RESULTS
Amyloid positivity was confirmed in 82 (82.8%) patients. Plasma p‐tau217 predicted amyloid status, with an area under the curve of 0.93. With a cutpoint (0.1795 pg/mL) based on the Youden index, this approach achieved 95.1% sensitivity, 94.1% specificity, 98.7% positive predictive value, and 80.0% negative predictive value (NPV). Higher external thresholds led to a lower NPV, demonstrating that cut points must be optimized for clinical stages.
DISCUSSION
These findings provide real‐world evidence supporting the clinical utility of p‐tau217 for ATT candidates.