Academic Journal
The myth of digital biomarkers in Alzheimer's disease: how to make them a reality.
| Τίτλος: | The myth of digital biomarkers in Alzheimer's disease: how to make them a reality. |
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| Συγγραφείς: | Au R; Department of Anatomy & Neurobiology, Boston University Chobanian & Avedisian School of Medicine.; Departments of Neurology, Medicine, and Framingham Heart Study, Boston University Chobanian & Avedisian School of Medicine School of Medicine.; Department of Epidemiology, Boston University School of Public Health., Gifford KA; Department of Anatomy & Neurobiology, Boston University Chobanian & Avedisian School of Medicine., Paschalidis IC; College of Engineering, Faculty of Computing & Data Sciences, and Hariri Institute for Computing, Boston University., Wighton P; Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Boston, Massachusetts., Levin M; Department of Anatomy & Neurobiology, Boston University Chobanian & Avedisian School of Medicine., Imam F; Gates Ventures.; Global Research Platforms, LLC, Kirkland, Washington, USA., Bose N; Gates Ventures.; Global Research Platforms, LLC, Kirkland, Washington, USA., Pratap A; Department of Anatomy & Neurobiology, Boston University Chobanian & Avedisian School of Medicine. |
| Πηγή: | Current opinion in psychiatry [Curr Opin Psychiatry] 2026 Jul 01; Vol. 39 (4), pp. 331-338. Date of Electronic Publication: 2026 Apr 29. |
| Τύπος έκδοσης: | Journal Article; Review |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 8809880 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1473-6578 (Electronic) Linking ISSN: 09517367 NLM ISO Abbreviation: Curr Opin Psychiatry Subsets: MEDLINE |
| Imprint Name(s): | Publication: Original Publication: Philadelphia, PA, USA : Gower Academic Journals, c1988- |
| Ιατρικοί όροι (MeSH): | Alzheimer Disease*/diagnosis , Biomarkers*/blood , Digital Technology*, Humans ; Digital Health ; United States ; United States Food and Drug Administration |
| Περίληψη: | Purpose of Review: With an estimated 41.1B digital devices, the term "digital biomarkers" has been increasingly bandied about in the research literature. There is, however, a significant disconnect between the presumption of digital biomarkers and the reality of digital biomarkers. Recent Findings: The research literature embraces the concept of digital biomarkers without concomitant evidence for validation of digital measures as biomarkers. Unlike imaging or blood-based biomarkers, there is a woeful lack of research dedicated to validating digital measures as biomarkers. This gap also presents an opportunity. Regulatory agencies worldwide have long-standing protocols used by pharmaceutical and biotech companies to stand up quality management systems (QMS) that track research from inception to regulatory approved submissions. The recent United States (US) Food and Drug Administration (FDA) approval of Alzheimer's disease (AD) plasma biomarkers is another example where successful QMS implementation provided the processes and transparency necessary to obtain approval. Regulatory guidelines for digital technology validation are more circumspect on validation pathways of AD digital biomarkers, but FDA provides a framework for building a QMS that could potentially do so. Summary: Building an open source QMS for AD digital biomarker validation will be a critical breakthrough for harnessing the potential of digital technologies for detection, monitoring and treatment of AD and related disorders. (Copyright © 2026 The Author(s). Published by Wolters Kluwer Health, Inc.) |
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| Contributed Indexing: | Keywords: digital biomarkers; digital technology; quality management system; regulatory agency validation |
| Substance Nomenclature: | 0 (Biomarkers) |
| Entry Date(s): | Date Created: 20260505 Date Completed: 20260716 Latest Revision: 20260813 |
| Update Code: | 20260813 |
| PubMed Central ID: | PMC13236039 |
| DOI: | 10.1097/YCO.0000000000001089 |
| PMID: | 42083983 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1473-6578 |
|---|---|
| DOI: | 10.1097/YCO.0000000000001089 |