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
- Institución
- Consejo Nacional de Investigaciones Científicas y Técnicas
- OAI Identificador
- oai:ri.conicet.gov.ar:11336/266870
Ver los metadatos del registro completo
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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 Técnicas2025-09-29T10:32:13Zoai: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:34982025-09-29 10:32:13.878CONICET 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 |
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eng |
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openAccess |
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application/pdf application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Elsevier |
publisher.none.fl_str_mv |
Elsevier |
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