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Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies
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Biomarkers.

Anna Mammel1, Ging-Yuek Robin Hsiung2, Ali Mousavi3,4

  • 1Neurocode USA Inc., Bellingham, WA, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 26, 2025
PubMed
Summary
This summary is machine-generated.

Plasma phosphorylated tau 217 (p-tau217) shows promise for Alzheimer's disease (AD) diagnosis. The ALZpath assay differentiated AD from other pathologies but not from AD with co-occurring conditions like DLB or vascular issues.

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Area of Science:

  • Neurology
  • Biomarker Discovery
  • Alzheimer's Disease Research

Background:

  • Blood-based biomarkers offer accessible diagnostics for Alzheimer's disease (AD).
  • Plasma phosphorylated tau 217 (p-tau217) is a promising biomarker for AD diagnosis and differential diagnosis.
  • Evaluating the ALZpath plasma p-tau217 assay for distinguishing AD from other pathologies is crucial for treatment access.

Purpose of the Study:

  • To evaluate the ALZpath plasma p-tau217 assay's performance in distinguishing Alzheimer's disease (AD) pathology.
  • To assess the assay's ability to differentiate AD from other neurodegenerative pathologies, including mixed pathologies.
  • To determine if plasma p-tau217 can differentiate AD with co-occurring conditions (DLB, vascular pathology, CAA) from AD alone.

Main Methods:

  • Analysis of autopsy-confirmed EDTA plasma samples (n=110) from patients with AD and other pathologies.
  • Utilized the ALZpath p-tau217 v2 assay on a Quanterix HD-X SIMOA Analyzer.
  • Cohort included AD only, AD with CAA, AD with DLB, AD with vascular pathology, AD with mixed pathologies, TDP-43 only, Synuclein only, and Tau only groups.

Main Results:

  • Plasma p-tau217 concentrations were significantly higher in AD cases compared to TDP-43 only, synuclein only, tau only, and mixed pathology groups (p < 0.001).
  • No statistically significant differences were observed in plasma p-tau217 levels between AD and AD with DLB, AD with vascular pathology, or AD with CAA groups.
  • Plasma p-tau217 levels could differentiate AD from non-AD pathologies but struggled with co-existing conditions.

Conclusions:

  • Plasma p-tau217 effectively differentiates AD from mixed pathologies and other non-AD neurodegenerative diseases.
  • The assay did not differentiate AD with DLB, vascular pathology, or CAA from AD alone, suggesting overlapping pathology.
  • Further research with autopsy-defined cohorts is necessary to fully elucidate plasma p-tau217's role in complex neurodegenerative cases.