Improving Alzheimer Diagnosis With Innovative Blood-Based Biomarker Tests and BD-Tau: Mike Miller, PhD

WATCH TIME: 4 minutes

"It's been interesting being involved in the field over the last few years, with the first disease-modifying therapies becoming available just in the last year or two. There’s been a dramatic increase in energy and enthusiasm within the field, along with rapid progress in our understanding of [Alzheimer disease]."

Studies showed that the amyloid-ß, tau, and neurodegeneration framework offers clinicians a cost-effective and scalable solution for diagnosing Alzheimer Disease (AD) and other dementias. Despite phosphorylated tau being an effective diagnostic marker in AD, total tau in cerebrospinal fluid (CSF) remains critical for pathological staging; however, plasma total tau measurements lack specificity because of the predominant presence of peripheral tau. Recently, brain-derived tau (BD-Tau) has become an emerging biomarker that has outperformed blood total tau and neurofilament light in distinguishing AD from other neurodegenerative diseases.

A new study showed that the Simoa BD-Tau assay (Quanterix) effectively measured BD-Tau in serum and plasma with high accuracy in a sample of patients who were either considered healthy controls, had mild cognitive impairment, or had mild AD from the BioHermes cohort (NCT04733989). Presented at the recently concluded 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 29 to November 1, in Madrid, Spain, by coauthor Mike Miller, PhD, chief operating officer at Quanterix Corporation, and colleagues, these findings suggest that the assay may provide a valuable tool to evaluate patients with AD in both diagnostic and clinical trial settings.¹

At the conference, Miller also presented on data of the company’s Simoa LucentAD 217 test in a multi-marker logistic regression model which showed high accuracy in amyloid classification for over one-half of intermediate cases that could not be classified with p-Tau 217 alone.² This result suggests that that the assay can assist with providing amyloid status certainty for a greater number of symptomatic patients who undergo assessment for AD.3 In a recent interview with NeurologyLive^®, Miller dived deeper into the clinical implications of the findings from the 2 presentations at CTAD 2024 and shared his perspective on how the company’s technology could impact future Alzheimer treatment and research efforts.

Click here for more coverage of CTAD 2024.

REFERENCES
1. Shi J, Sheehy C, Herrera J, et al. Fully Automated Ultrasensitive Simoa Assay for Brain-Derived Tau: Enhancing the Characterization of Alzheimer’s Disease-Related Neurodegeneration in Blood. Presented at: 2024 CTAD; October 29-November 1; Madrid, Spain. P127.
2. Wilson D, Copeland K, Khare M, et al. Clinical and Analytical Validation of LucentAD Complete, Multi-Marker Algorithmic Lab Developed Test (LDT) for High Accuracy Plasma Detection of Amyloid Pathology. Presented at: 2024 CTAD; October 29-November 1; Madrid, Spain. P139.
3. New Multi-Marker Blood Test from Lucent Diagnostics Increases the Number of Patients Receiving Early Alzheimer’s Disease Diagnostic Information. News Release. Quanterix Corporation. Published October 28, 2024. Accessed November 8, 2024. https://www.quanterix.com/press-releases/new-multi-marker-blood-test-from-lucent-diagnostics-increases-the-number-of-patients-receiving-early-alzheimers-disease-diagnostic-information/