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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...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2020
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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 |
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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 |
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