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Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers

Frisoni, Giovanni B.; Boccardi, Marina; Barkhof, Frederik; Blennow, Kaj LU ; Cappa, Stefano F; Chiotis, Konstantinos; Démonet, Jean Francois; Garibotto, Valentina; Giannakopoulos, Panteleimon and Gietl, Anton, et al. (2017) In The Lancet Neurology 16(8). p.661-676
Abstract

The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care. We have developed a strategic five-phase roadmap to foster the clinical validation of biomarkers in Alzheimer's disease, adapted from the... (More)

The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care. We have developed a strategic five-phase roadmap to foster the clinical validation of biomarkers in Alzheimer's disease, adapted from the approach for cancer biomarkers. Sufficient evidence of analytical validity (phase 1 of a structured framework adapted from oncology) is available for all biomarkers, but their clinical validity (phases 2 and 3) and clinical utility (phases 4 and 5) are incomplete. To complete these phases, research priorities include the standardisation of the readout of these assays and thresholds for normality, the evaluation of their performance in detecting early disease, the development of diagnostic algorithms comprising combinations of biomarkers, and the development of clinical guidelines for the use of biomarkers in qualified memory clinics.

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published
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The Lancet Neurology
volume
16
issue
8
pages
16 pages
publisher
Lancet Ltd
external identifiers
  • scopus:85023199961
  • wos:000405201300022
ISSN
1474-4422
DOI
10.1016/S1474-4422(17)30159-X
language
English
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yes
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145259c1-a2ac-476e-b62d-d030e8e18779
date added to LUP
2017-08-01 11:27:24
date last changed
2018-05-20 04:36:20
@article{145259c1-a2ac-476e-b62d-d030e8e18779,
  abstract     = {<p>The diagnosis of Alzheimer's disease can be improved by the use of biological measures. Biomarkers of functional impairment, neuronal loss, and protein deposition that can be assessed by neuroimaging (ie, MRI and PET) or CSF analysis are increasingly being used to diagnose Alzheimer's disease in research studies and specialist clinical settings. However, the validation of the clinical usefulness of these biomarkers is incomplete, and that is hampering reimbursement for these tests by health insurance providers, their widespread clinical implementation, and improvements in quality of health care. We have developed a strategic five-phase roadmap to foster the clinical validation of biomarkers in Alzheimer's disease, adapted from the approach for cancer biomarkers. Sufficient evidence of analytical validity (phase 1 of a structured framework adapted from oncology) is available for all biomarkers, but their clinical validity (phases 2 and 3) and clinical utility (phases 4 and 5) are incomplete. To complete these phases, research priorities include the standardisation of the readout of these assays and thresholds for normality, the evaluation of their performance in detecting early disease, the development of diagnostic algorithms comprising combinations of biomarkers, and the development of clinical guidelines for the use of biomarkers in qualified memory clinics.</p>},
  author       = {Frisoni, Giovanni B. and Boccardi, Marina and Barkhof, Frederik and Blennow, Kaj and Cappa, Stefano F and Chiotis, Konstantinos and Démonet, Jean Francois and Garibotto, Valentina and Giannakopoulos, Panteleimon and Gietl, Anton and Hansson, Oskar and Herholz, Karl and Jack, Clifford R and Nobili, Flavio and Nordberg, Agneta and Snyder, Heather M. and Ten Kate, Mara and Varrone, Andrea and Albanese, Emiliano and Becker, Stefanie and Bossuyt, Patrick and Carrillo, Maria C. and Cerami, Chiara and Dubois, Bruno and Gallo, Valentina and Giacobini, Ezio and Gold, Gabriel and Hurst, Samia A. and Lönneborg, Anders and Lovblad, Karl Olof and Mattsson, Niklas and Molinuevo, José Luis and Monsch, Andreas U. and Mosimann, Urs and Padovani, Alessandro and Picco, Agnese and Porteri, Corinna and Ratib, Osman and Saint-Aubert, Laure and Scerri, Charles and Scheltens, Philip and Schott, Jonathan M and Sonni, Ida and Teipel, Stefan and Vineis, Paolo and Visser, Pieter Jelle and Yasui, Yutaka and Winblad, Bengt},
  issn         = {1474-4422},
  language     = {eng},
  month        = {08},
  number       = {8},
  pages        = {661--676},
  publisher    = {Lancet Ltd},
  series       = {The Lancet Neurology},
  title        = {Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers},
  url          = {http://dx.doi.org/10.1016/S1474-4422(17)30159-X},
  volume       = {16},
  year         = {2017},
}