Insights into the use of biomarkers in clinical trials in Alzheimer's disease
Pascoal, Tharick (Department of Neurology. School of Medicine. University of Pittsburgh)
Aguzzoli, C.S. (Brain Institute of Rio Grande do Sul. PUCRS)
Lussier, F.Z. (University of Pittsburgh)
Crivelli, L. (Fleni)
Suemoto, C.K. (University of São Paulo Medical School)
Fortea, Juan (Institut de Recerca Sant Pau)
Rosa-Neto, P. (McGill University Research Centre for Studies in Aging)
Zimmer, E.R. (Universidade Federal do Rio Grande do Sul)
Ferreira, P.C.L. (University of Pittsburgh)
Bellaver, B. (University of Pittsburgh)
Universitat Autònoma de Barcelona

Data:	2024
Resum:	Biomarkers have been instrumental in population selection and disease monitoring in clinical trials of recently FDA-approved drugs targeting amyloid-β to slow the progression of Alzheimer's disease (AD). As new therapeutic strategies and biomarker techniques emerge, the importance of biomarkers in drug development is growing exponentially. In this emerging landscape, biomarkers are expected to serve a wide range of contexts of use in clinical trials focusing on AD and related dementias. The joint FDA-NIH BEST (Biomarkers, EndpointS, and other Tools) framework provides standardised terminology to facilitate communication among stakeholders in this increasingly complex field. This review explores various applications of biomarkers relevant to AD clinical trials, using the BEST resource as a reference. For simplicity, we predominantly provide contextual characterizations of biomarkers use from the perspective of drugs targeting amyloid-β and tau proteins. However, general definitions and concepts can be extrapolated to other targets.
Ajuts:	Instituto de Salud Carlos III PI20/01473 Instituto de Salud Carlos III PI23/01786
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article de revisió ; recerca ; Versió publicada
Publicat a:	EBioMedicine, Vol. 108 (october 2024) , p. 105322, ISSN 2352-3964

DOI: 10.1016/j.ebiom.2024.105322
PMID: 39366844

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