Insights into the use of biomarkers in clinical trials in Alzheimer's disease

Autores
Pascoal, Tharick A.; Aguzzoli, Cristiano S.; Lussier, Firoza Z.; Crivelli, Lucía; Suemoto, Claudia K.; Fortea, Juan; Rosa Neto, Pedro; Zimmer, Eduardo R.; Ferreira, Pamela C .L.; Bellaver, Bruna
Año de publicación
2024
Idioma
inglés
Tipo de recurso
artículo
Estado
versión publicada
Descripción
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 increasinglycomplex 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.
Fil: Pascoal, Tharick A.. University of Pittsburgh; Estados Unidos
Fil: Aguzzoli, Cristiano S.. University of Pittsburgh; Estados Unidos
Fil: Lussier, Firoza Z.. University of Pittsburgh; Estados Unidos
Fil: Crivelli, Lucía. Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia. Instituto de Neurociencias - Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Neurociencias; Argentina
Fil: Suemoto, Claudia K.. Universidade de Sao Paulo; Brasil
Fil: Fortea, Juan. Universitat Autònoma de Barcelona; España
Fil: Rosa Neto, Pedro. McGill University. Montreal Neurological Institute and Hospital; Canadá
Fil: Zimmer, Eduardo R.. Universidade Federal do Rio Grande do Sul; Brasil
Fil: Ferreira, Pamela C .L.. University of Pittsburgh; Estados Unidos
Fil: Bellaver, Bruna. University of Pittsburgh; Estados Unidos
Materia
Alzheimer’s disease
Clinical trials
Biomarkers
Disease-modifying therapies
Nivel de accesibilidad
acceso abierto
Condiciones de uso
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
Repositorio
CONICET Digital (CONICET)
Institución
Consejo Nacional de Investigaciones Científicas y Técnicas
OAI Identificador
oai:ri.conicet.gov.ar:11336/266870
Acceder
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network_name_str CONICET Digital (CONICET)
spelling Insights into the use of biomarkers in clinical trials in Alzheimer's diseasePascoal, Tharick A.Aguzzoli, Cristiano S.Lussier, Firoza Z.Crivelli, LucíaSuemoto, Claudia K.Fortea, JuanRosa Neto, PedroZimmer, Eduardo R.Ferreira, Pamela C .L.Bellaver, BrunaAlzheimer’s diseaseClinical trialsBiomarkersDisease-modifying therapieshttps://purl.org/becyt/ford/3.3https://purl.org/becyt/ford/3Biomarkers 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 increasinglycomplex 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.Fil: Pascoal, Tharick A.. University of Pittsburgh; Estados UnidosFil: Aguzzoli, Cristiano S.. University of Pittsburgh; Estados UnidosFil: Lussier, Firoza Z.. University of Pittsburgh; Estados UnidosFil: Crivelli, Lucía. Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia. Instituto de Neurociencias - Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Neurociencias; ArgentinaFil: Suemoto, Claudia K.. Universidade de Sao Paulo; BrasilFil: Fortea, Juan. Universitat Autònoma de Barcelona; EspañaFil: Rosa Neto, Pedro. McGill University. Montreal Neurological Institute and Hospital; CanadáFil: Zimmer, Eduardo R.. Universidade Federal do Rio Grande do Sul; BrasilFil: Ferreira, Pamela C .L.. University of Pittsburgh; Estados UnidosFil: Bellaver, Bruna. University of Pittsburgh; Estados UnidosElsevier2024-10info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttp://purl.org/coar/resource_type/c_6501info:ar-repo/semantics/articuloapplication/pdfapplication/pdfapplication/pdfhttp://hdl.handle.net/11336/266870Pascoal, Tharick A.; Aguzzoli, Cristiano S.; Lussier, Firoza Z.; Crivelli, Lucía; Suemoto, Claudia K.; et al.; Insights into the use of biomarkers in clinical trials in Alzheimer's disease; Elsevier; eBioMedicine; 108; 10-2024; 1-132352-3964CONICET DigitalCONICETenginfo:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S235239642400358Xinfo:eu-repo/semantics/altIdentifier/doi/10.1016/j.ebiom.2024.105322info:eu-repo/semantics/openAccesshttps://creativecommons.org/licenses/by-nc-nd/2.5/ar/reponame:CONICET Digital (CONICET)instname:Consejo Nacional de Investigaciones Científicas y Técnicas2025-10-15T15:29:34Zoai:ri.conicet.gov.ar:11336/266870instacron:CONICETInstitucionalhttp://ri.conicet.gov.ar/Organismo científico-tecnológicoNo correspondehttp://ri.conicet.gov.ar/oai/requestdasensio@conicet.gov.ar; lcarlino@conicet.gov.arArgentinaNo correspondeNo correspondeNo correspondeopendoar:34982025-10-15 15:29:35.111CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicasfalse
dc.title.none.fl_str_mv Insights into the use of biomarkers in clinical trials in Alzheimer's disease
title Insights into the use of biomarkers in clinical trials in Alzheimer's disease
spellingShingle Insights into the use of biomarkers in clinical trials in Alzheimer's disease
Pascoal, Tharick A.
Alzheimer’s disease
Clinical trials
Biomarkers
Disease-modifying therapies
title_short Insights into the use of biomarkers in clinical trials in Alzheimer's disease
title_full Insights into the use of biomarkers in clinical trials in Alzheimer's disease
title_fullStr Insights into the use of biomarkers in clinical trials in Alzheimer's disease
title_full_unstemmed Insights into the use of biomarkers in clinical trials in Alzheimer's disease
title_sort Insights into the use of biomarkers in clinical trials in Alzheimer's disease
dc.creator.none.fl_str_mv Pascoal, Tharick A.
Aguzzoli, Cristiano S.
Lussier, Firoza Z.
Crivelli, Lucía
Suemoto, Claudia K.
Fortea, Juan
Rosa Neto, Pedro
Zimmer, Eduardo R.
Ferreira, Pamela C .L.
Bellaver, Bruna
author Pascoal, Tharick A.
author_facet Pascoal, Tharick A.
Aguzzoli, Cristiano S.
Lussier, Firoza Z.
Crivelli, Lucía
Suemoto, Claudia K.
Fortea, Juan
Rosa Neto, Pedro
Zimmer, Eduardo R.
Ferreira, Pamela C .L.
Bellaver, Bruna
author_role author
author2 Aguzzoli, Cristiano S.
Lussier, Firoza Z.
Crivelli, Lucía
Suemoto, Claudia K.
Fortea, Juan
Rosa Neto, Pedro
Zimmer, Eduardo R.
Ferreira, Pamela C .L.
Bellaver, Bruna
author2_role author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Alzheimer’s disease
Clinical trials
Biomarkers
Disease-modifying therapies
topic Alzheimer’s disease
Clinical trials
Biomarkers
Disease-modifying therapies
purl_subject.fl_str_mv https://purl.org/becyt/ford/3.3
https://purl.org/becyt/ford/3
dc.description.none.fl_txt_mv 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 increasinglycomplex 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.
Fil: Pascoal, Tharick A.. University of Pittsburgh; Estados Unidos
Fil: Aguzzoli, Cristiano S.. University of Pittsburgh; Estados Unidos
Fil: Lussier, Firoza Z.. University of Pittsburgh; Estados Unidos
Fil: Crivelli, Lucía. Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia. Instituto de Neurociencias - Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Ciudad Universitaria. Instituto de Neurociencias; Argentina
Fil: Suemoto, Claudia K.. Universidade de Sao Paulo; Brasil
Fil: Fortea, Juan. Universitat Autònoma de Barcelona; España
Fil: Rosa Neto, Pedro. McGill University. Montreal Neurological Institute and Hospital; Canadá
Fil: Zimmer, Eduardo R.. Universidade Federal do Rio Grande do Sul; Brasil
Fil: Ferreira, Pamela C .L.. University of Pittsburgh; Estados Unidos
Fil: Bellaver, Bruna. University of Pittsburgh; Estados Unidos
description 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 increasinglycomplex 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.
publishDate 2024
dc.date.none.fl_str_mv 2024-10
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
http://purl.org/coar/resource_type/c_6501
info:ar-repo/semantics/articulo
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/11336/266870
Pascoal, Tharick A.; Aguzzoli, Cristiano S.; Lussier, Firoza Z.; Crivelli, Lucía; Suemoto, Claudia K.; et al.; Insights into the use of biomarkers in clinical trials in Alzheimer's disease; Elsevier; eBioMedicine; 108; 10-2024; 1-13
2352-3964
CONICET Digital
CONICET
url http://hdl.handle.net/11336/266870
identifier_str_mv Pascoal, Tharick A.; Aguzzoli, Cristiano S.; Lussier, Firoza Z.; Crivelli, Lucía; Suemoto, Claudia K.; et al.; Insights into the use of biomarkers in clinical trials in Alzheimer's disease; Elsevier; eBioMedicine; 108; 10-2024; 1-13
2352-3964
CONICET Digital
CONICET
dc.language.none.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv info:eu-repo/semantics/altIdentifier/url/https://linkinghub.elsevier.com/retrieve/pii/S235239642400358X
info:eu-repo/semantics/altIdentifier/doi/10.1016/j.ebiom.2024.105322
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
eu_rights_str_mv openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/2.5/ar/
dc.format.none.fl_str_mv application/pdf
application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:CONICET Digital (CONICET)
instname:Consejo Nacional de Investigaciones Científicas y Técnicas
reponame_str CONICET Digital (CONICET)
collection CONICET Digital (CONICET)
instname_str Consejo Nacional de Investigaciones Científicas y Técnicas
repository.name.fl_str_mv CONICET Digital (CONICET) - Consejo Nacional de Investigaciones Científicas y Técnicas
repository.mail.fl_str_mv dasensio@conicet.gov.ar; lcarlino@conicet.gov.ar
_version_ 1846083435253202944
score 13.22299

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