Article Impact Level: HIGH Data Quality: STRONG Summary of Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, 17(1), e70080. https://doi.org/10.1002/dad2.70080 Dr. Adam H. Dyer et al.
Points
- The study assessed a fully automated plasma phosphorylated tau (p-tau217) immunoassay for the detection of amyloid beta (Aβ) pathology in individuals with mild cognitive impairment (MCI) or mild dementia.
- The research examined 148 participants, comprising 101 individuals with mild cognitive impairment (MCI) and 47 with mild dementia, utilizing paired plasma and cerebrospinal fluid (CSF) samples. Plasma p-tau217 levels were quantified using the Lumipulse immunoassay platform to evaluate its efficacy in identifying CSF-defined Aβ positivity.
- Plasma p-tau217 concentrations were more than four times elevated in individuals who tested positive for Aβ. The area under the curve (AUC) for detecting Aβ status was 0.92 (95% confidence interval: 0.87–0.97), indicating high diagnostic accuracy.
- Implementing sensitivity and specificity thresholds of 90%, 95%, and 97.5% for plasma p-tau217 could have reduced the necessity for more than half of the lumbar punctures in the study cohort.
- The plasma p-tau217 immunoassay serves as a reliable, non-invasive method for detecting Aβ pathology in individuals with mild cognitive impairment and mild dementia; however, additional validation in varied populations is necessary for wider clinical implementation.
Summary
This research aimed to assess the efficacy of a fully automated plasma phosphorylated tau (p-tau217) immunoassay in identifying amyloid beta (Aβ) pathology in patients with mild cognitive impairment (MCI) or mild dementia. This research included paired plasma and cerebrospinal fluid (CSF) samples from 148 subjects (average age 69.4 ± 6.5 years, 54.1% female), comprising 101 individuals diagnosed with mild cognitive impairment (MCI) and 47 with mild dementia. Plasma p-tau217 levels were quantified using the Lumipulse immunoassay platform, and the capacity of plasma p-tau217 to detect CSF-defined Aβ positivity was evaluated.
The findings indicated that plasma p-tau217 levels were over four times greater in individuals who tested positive for Aβ compared to those who tested negative. The AUC for plasma p-tau217 in identifying Aβ status was 0.92, with a 95% confidence interval ranging from 0.87 to 0.97. This indicates a high level of precision in identifying Aβ pathology using plasma p-tau217. Furthermore, implementing sensitivity and specificity thresholds of 90%, 95%, and 97.5% for plasma p-tau217 might have reduced the necessity for more than half of the lumbar punctures conducted in this group.
The results endorse the clinical application of fully automated plasma p-tau217 immunoassays as a dependable, non-invasive substitute for lumbar puncture in identifying Aβ pathology among patients with MCI and mild dementia. The findings are encouraging; however, the research highlights the necessity for additional validation across varied populations to establish the broader applicability and clinical relevance of this biomarker strategy in everyday practice.
Link to the article: https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/dad2.70080
References Dyer, A. H., Dunne, J., Dolphin, H., Morrison, L., O’Connor, A., Fullam, S., Kenny, T., Fallon, A., O’Dowd, S., Bourke, N. M., Conlon, N. P., Kennelly, S. P., & for the TIMC‐BRAiN Study Group. (2025). Clinical performance of the fully automated Lumipulse plasma p‐tau217 assay in mild cognitive impairment and mild dementia. Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, 17(1), e70080. https://doi.org/10.1002/dad2.70080
