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Use of Biomarkers in Ongoing Research Protocols on Alzheimer’s Disease
- 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.
- Subjects :
- medicine.medical_specialty
Tau pathology
Medicine (miscellaneous)
lcsh:Medicine
Review
Disease
03 medical and health sciences
0302 clinical medicine
Intervention (counseling)
Medicine
030212 general & internal medicine
Intensive care medicine
clinical trials
business.industry
lcsh:R
biomarkers
drug development
Alzheimer’s disease
Biomarkers
Clinical trials
Diagnostic research
Drug development
Clinical trial
Safety profile
Tolerability
Biomarker (medicine)
business
030217 neurology & neurosurgery
diagnostic research
Subjects
Details
- Language :
- English
- ISSN :
- 20754426
- Volume :
- 10
- Issue :
- 68
- Database :
- OpenAIRE
- Journal :
- Journal of Personalized Medicine
- Accession number :
- edsair.doi.dedup.....10e24c102089b7dbd37a10a05ca4c101