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Plasma Biomarkers of AD Emerging as Essential Tools for Drug Development: An EU/US CTAD Task Force Report
R J Bateman1, K Blennow, R Doody
1Randall J. Bateman, Washington University School of Medicine, St. Louis, MO, USA, batemanr@wustl.edu.
Developing reliable Alzheimer's disease (AD) blood biomarkers is crucial for screening and clinical trials. Advances in plasma amyloid beta and neurofilament light protein show promise for detecting AD pathology and neurodegeneration.
Area of Science:
- Neurology
- Biomarker Discovery
- Clinical Trials
Background:
- Urgent need for sensitive blood-based biomarkers for Alzheimer's disease (AD) screening and clinical trial efficiency.
- The European Union-North American Clinical Trials in Alzheimer's Disease (EU/US CTAD) Task Force convened in 2018 to discuss AD biomarker development.
- Current limitations in existing biomarkers necessitate advancements in blood-based diagnostics.
Purpose of the Study:
- To review the current status of blood-based Alzheimer's disease biomarker development.
- To highlight recent technological improvements in assessing AD biomarkers in blood.
- To emphasize the importance of international collaboration for advancing biomarker technologies.
Main Methods:
- Discussion and review of recent advancements in blood-based biomarker technologies presented at the EU/US CTAD Task Force meeting.
- Assessment of plasma amyloid beta, neurofilament light protein, and tau levels.
- Consideration of -omics and other analytical approaches for blood sample analysis.
Main Results:
- Improved technologies for plasma amyloid beta assessment suggest blood tests can accurately estimate brain amyloid positivity.
- Plasma neurofilament light protein shows potential as a marker for neurodegeneration, though not specific to AD.
- Plasma tau shows promise but has weak correlation with cerebrospinal fluid (CSF) tau, possibly due to rapid blood clearance.
Conclusions:
- Blood-based biomarkers, particularly plasma amyloid beta and neurofilament light, offer a promising avenue for AD diagnosis and monitoring.
- Further research into plasma tau and -omics approaches may yield deeper insights into AD mechanisms and predictive profiles.
- International, multidisciplinary collaboration is essential to accelerate the development and validation of these critical diagnostic tools.
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