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

Authors :
Giuseppe Bruno
Ilaria Bacigalupo
Francesco Sciancalepore
Marco Toccaceli Blasi
Nicola Vanacore
Giulia Remoli
Marco Canevelli
Martina Valletta
Matteo Cesari
Source :
Journal of Personalized Medicine, Vol 10, Iss 68, p 68 (2020), Journal of Personalized Medicine
Publication Year :
2020
Publisher :
MDPI AG, 2020.

Abstract

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.

Details

Language :
English
ISSN :
20754426
Volume :
10
Issue :
68
Database :
OpenAIRE
Journal :
Journal of Personalized Medicine
Accession number :
edsair.doi.dedup.....10e24c102089b7dbd37a10a05ca4c101