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Fluid biomarkers in the context of amyloid-targeting disease-modifying treatments in Alzheimer’s disease
Abstract
Clinical management and therapeutics development for Alzheimer's disease (AD) have entered a new era, with recent approvals of monoclonal antibody therapies targeting the underlying pathophysiology of the disease and modifying its trajectory. Imaging and fluid biomarkers are becoming increasingly important in the clinical development of AD therapeutics. This review focuses on the evidence of fluid biomarkers from recent amyloid-β-targeting clinical trials, summarizing biomarker data across 12 trials. It further proposes a simple framework to put biomarker guidance in the context of amyloid-pathway-targeted disease modification, delineates factors that impact biomarker data in clinical trials, and highlights knowledge gaps and future directions. Increased knowledge and data on biomarkers in the context of disease progression and disease modification will help to better design future AD trials and guide the clinical management of patients on AD-modifying therapies, bringing us closer to the implementation of precision medicine in AD.
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The level of plasma p-tau217 is correlated with amyloid and tau pathology on PET imaging and has proven useful in identifying study participants for trials assessing the effects of anti-amyloid therapies.
“The level of plasma p-tau217 is correlated with amyloid and tau pathology on PET imaging and has proven useful in identifying study participants for trials assessing the effects of anti-amyloid therapies [11–13].”
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Di Caro, V., Cho, E., Thiel, J., Lizama, B. N., Koel-Simmelink, M. J. A., Pandey, K., Duong, D., Seyfried, N. T., Grundman, M., Teunissen, C. E., et al. (2026) · Alzheimer's Research & Therapy · doi:10.1186/s13195-026-02025-4 · Cited by 1
Metadata
- Authors
- Hu, Y., Cho, M., Sachdev, P., Dage, J., Hendrix, S., Hansson, O., Bateman, R. J., & Hampel, H.
- ORCID
- Hampel, Harald
- Venue
- Med
- Publisher
- Elsevier BV
- Published
- 2024-10
- Volume
- 5
- Issue
- 10
- Pages
- 1206-1226
- ISSN
- 2666-6340
- Cited by
- 42
- References
- 22
- Language
- en
- Licence
- Funders
- Eisai
- Catholic Medical Center
- National Institutes of Health (LRAP23, R01 AG077202, U01 AG057195, U24 AG082930, U54 AG065181, MJFF-023365, U01 AG082350, U54 AG054345, U19 AG074879, R01 AG068193, P30 AG072976, R01 AG072474, RD005665, U24 AG021886)
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