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.

Use of biomarkers in ongoing research protocols on alzheimer’s disease / Canevelli, M.; Remoli, G.; Bacigalupo, I.; Valletta, M.; Blasi, M. T.; Sciancalepore, F.; Bruno, G.; Cesari, M.; Vanacore, N.. - In: JOURNAL OF PERSONALIZED MEDICINE. - ISSN 2075-4426. - 10:3(2020), pp. 1-11. [10.3390/jpm10030068]

Use of biomarkers in ongoing research protocols on alzheimer’s disease

Canevelli M.;Valletta M.;Sciancalepore F.;Bruno G.;Vanacore N.
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.
2020
Alzheimer’s disease; Biomarkers; Clinical trials; Diagnostic research; Drug development
01 Pubblicazione su rivista::01g Articolo di rassegna (Review)
Use of biomarkers in ongoing research protocols on alzheimer’s disease / Canevelli, M.; Remoli, G.; Bacigalupo, I.; Valletta, M.; Blasi, M. T.; Sciancalepore, F.; Bruno, G.; Cesari, M.; Vanacore, N.. - In: JOURNAL OF PERSONALIZED MEDICINE. - ISSN 2075-4426. - 10:3(2020), pp. 1-11. [10.3390/jpm10030068]
File allegati a questo prodotto
File Dimensione Formato  
Canevelli_Use of Biomarkers_2020.pdf

accesso aperto

Tipologia: Versione editoriale (versione pubblicata con il layout dell'editore)
Licenza: Creative commons
Dimensione 894.2 kB
Formato Adobe PDF
894.2 kB Adobe PDF

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1472730
Citazioni
  • ???jsp.display-item.citation.pmc??? 4
  • Scopus 10
  • ???jsp.display-item.citation.isi??? 9
social impact