Cargando…

Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease

The present study aimed to describe and discuss the state of the art of biomarker use in ongoing Alzheimer’s disease (AD) research. A review of 222 ongoing phase 1, 2, 3, and 4 protocols registered in the clinicaltrials.gov database was performed. All the trials (i) enrolling subjects with clinical...

Descripción completa

Detalles Bibliográficos
Autores principales: Canevelli, Marco, Remoli, Giulia, Bacigalupo, Ilaria, Valletta, Martina, Toccaceli Blasi, Marco, Sciancalepore, Francesco, Bruno, Giuseppe, Cesari, Matteo, Vanacore, Nicola
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564515/
https://www.ncbi.nlm.nih.gov/pubmed/32722106
http://dx.doi.org/10.3390/jpm10030068
_version_ 1783595732986494976
author Canevelli, Marco
Remoli, Giulia
Bacigalupo, Ilaria
Valletta, Martina
Toccaceli Blasi, Marco
Sciancalepore, Francesco
Bruno, Giuseppe
Cesari, Matteo
Vanacore, Nicola
author_facet Canevelli, Marco
Remoli, Giulia
Bacigalupo, Ilaria
Valletta, Martina
Toccaceli Blasi, Marco
Sciancalepore, Francesco
Bruno, Giuseppe
Cesari, Matteo
Vanacore, Nicola
author_sort Canevelli, Marco
collection PubMed
description The present study aimed to describe and discuss the state of the art of biomarker use in ongoing Alzheimer’s disease (AD) research. A review of 222 ongoing phase 1, 2, 3, and 4 protocols registered in the clinicaltrials.gov database was performed. All the trials (i) enrolling subjects with clinical disturbances and/or preclinical diagnoses falling within the AD continuum; and (ii) testing the efficacy and/or safety/tolerability of a therapeutic intervention, were analyzed. The use of biomarkers of amyloid deposition, tau pathology, and neurodegeneration among the eligibility criteria and/or study outcomes was assessed. Overall, 58.2% of ongoing interventional studies on AD adopt candidate biomarkers. They are mostly adopted by studies at the preliminary stages of the drug development process to explore the safety profile of novel therapies, and to provide evidence of target engagement and disease-modifying properties. The biologically supported selection of participants is mostly based on biomarkers of amyloid deposition, whereas the use of biomarkers as study outcomes mostly relies on markers of neurodegeneration. Biomarkers play an important role in the design and conduction of research protocols targeting AD. Nevertheless, their clinical validity, utility, and cost-effectiveness in the “real world” remain to be clarified.
format Online
Article
Text
id pubmed-7564515
institution National Center for Biotechnology Information
language English
publishDate 2020
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-75645152020-10-29 Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease Canevelli, Marco Remoli, Giulia Bacigalupo, Ilaria Valletta, Martina Toccaceli Blasi, Marco Sciancalepore, Francesco Bruno, Giuseppe Cesari, Matteo Vanacore, Nicola J Pers Med Review The present study aimed to describe and discuss the state of the art of biomarker use in ongoing Alzheimer’s disease (AD) research. A review of 222 ongoing phase 1, 2, 3, and 4 protocols registered in the clinicaltrials.gov database was performed. All the trials (i) enrolling subjects with clinical disturbances and/or preclinical diagnoses falling within the AD continuum; and (ii) testing the efficacy and/or safety/tolerability of a therapeutic intervention, were analyzed. The use of biomarkers of amyloid deposition, tau pathology, and neurodegeneration among the eligibility criteria and/or study outcomes was assessed. Overall, 58.2% of ongoing interventional studies on AD adopt candidate biomarkers. They are mostly adopted by studies at the preliminary stages of the drug development process to explore the safety profile of novel therapies, and to provide evidence of target engagement and disease-modifying properties. The biologically supported selection of participants is mostly based on biomarkers of amyloid deposition, whereas the use of biomarkers as study outcomes mostly relies on markers of neurodegeneration. Biomarkers play an important role in the design and conduction of research protocols targeting AD. Nevertheless, their clinical validity, utility, and cost-effectiveness in the “real world” remain to be clarified. MDPI 2020-07-24 /pmc/articles/PMC7564515/ /pubmed/32722106 http://dx.doi.org/10.3390/jpm10030068 Text en © 2020 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Review
Canevelli, Marco
Remoli, Giulia
Bacigalupo, Ilaria
Valletta, Martina
Toccaceli Blasi, Marco
Sciancalepore, Francesco
Bruno, Giuseppe
Cesari, Matteo
Vanacore, Nicola
Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease
title Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease
title_full Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease
title_fullStr Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease
title_full_unstemmed Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease
title_short Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease
title_sort use of biomarkers in ongoing research protocols on alzheimer’s disease
topic Review
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7564515/
https://www.ncbi.nlm.nih.gov/pubmed/32722106
http://dx.doi.org/10.3390/jpm10030068
work_keys_str_mv AT canevellimarco useofbiomarkersinongoingresearchprotocolsonalzheimersdisease
AT remoligiulia useofbiomarkersinongoingresearchprotocolsonalzheimersdisease
AT bacigalupoilaria useofbiomarkersinongoingresearchprotocolsonalzheimersdisease
AT vallettamartina useofbiomarkersinongoingresearchprotocolsonalzheimersdisease
AT toccaceliblasimarco useofbiomarkersinongoingresearchprotocolsonalzheimersdisease
AT sciancaleporefrancesco useofbiomarkersinongoingresearchprotocolsonalzheimersdisease
AT brunogiuseppe useofbiomarkersinongoingresearchprotocolsonalzheimersdisease
AT cesarimatteo useofbiomarkersinongoingresearchprotocolsonalzheimersdisease
AT vanacorenicola useofbiomarkersinongoingresearchprotocolsonalzheimersdisease