Can We Use Blood Biomarkers as Entry Criteria and for Monitoring Drug Treatment Effects in Clinical Trials? A Report from the EU/US CTAD Task Force

D. Angioni*, O. Hansson, R. J. Bateman, C. Rabe, M. Toloue, J. B. Braunstein, S. Agus, J. R. Sims, T. Bittner, M. C. Carrillo, H. Fillit, C. L. Masters, S. Salloway, P. Aisen, M. Weiner, B. Vellas, S. Gauthier, EU/US/CTAD Task Force, Lewis Penny

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

In randomized clinical trials (RCTs) for Alzheimer’s Disease (AD), cerebrospinal fluid (CSF) and positron emission tomography (PET) biomarkers are currently used for the detection and monitoring of AD pathological features. The use of less resource-intensive plasma biomarkers could decrease the burden to study volunteers and limit costs and time for study enrollment. Blood-based markers (BBMs) could thus play an important role in improving the design and the conduct of RCTs on AD. It remains to be determined if the data available on BBMs are strong enough to replace CSF and PET biomarkers as entry criteria and monitoring tools in RCTs.

Original languageEnglish
Pages (from-to)418-425
Number of pages8
JournalJournal of Prevention of Alzheimer's Disease
Volume10
Issue number3
Early online date13 Jun 2023
DOIs
Publication statusPublished - Sept 2023

Keywords

  • Alzheimer’s disease
  • amyloid
  • monitoring
  • randomized clinical trials
  • screening
  • tau

Fingerprint

Dive into the research topics of 'Can We Use Blood Biomarkers as Entry Criteria and for Monitoring Drug Treatment Effects in Clinical Trials? A Report from the EU/US CTAD Task Force'. Together they form a unique fingerprint.

Cite this