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Title: Strategic roadmap for an early diagnosis of Alzheimer’s disease based on biomarkers
Authors: Frisoni, Giovanni B.
Boccardi, Marina
Barkhof, Frederik
Blennow, Kaj
Cappa, Stefano
Chiotis, Konstantinos
Demonet, Jean-Francois
Garibotto, Valentina
Giannakopoulos, Panteleimon
Gietl, Anton
Hansson, Oskar
Herholz, Karl
Jack, Clifford R.
Nobili, Flavio
Nordberg, Agneta
Snyder, Heather M.
Kate, Mara Ten
Varrone, Andrea
Albanese, Emiliano
Becker, Stefanie
Bossuyt, Patrick
Carrillo, Maria C.
Cerami, Chiara
Dubois, Bruno
Gallo, Valentina
Giacobini, Ezio
Gold, Gabriel
Hurst, Samia
Lonneborg, Anders
Lovblad, Karl-Olof
Mattsson, Niklas
Molinuevo, Jose-Luis
Monsch, Andreas U.
Mosimann, Urs
Padovani, Alessandro
Picco, Agnese
Porteri, Corinna
Ratib, Osman
Saint-Aubert, Laure
Scerri, Charles
Scheltens, Philip
Schott, Jonathan M.
Sonni, Ida
Teipel, Stefan
Vineis, Paolo
Visser, Pieter Jelle
Yasui, Yutaka
Winblad, Bengt
Keywords: Alzheimer's disease
Early diagnosis
Validation studies as topic
Tomography, Emission
Cerebrospinal fluid proteins
Issue Date: 2017
Publisher: The Lancet Publishing Group
Citation: Frisoni, G. B., Boccardi, M., Barkhof, F., Blennow, K., Cappa, S., Chiotis, K.,… Winblad, B. (2017). Strategic roadmap for an early diagnosis of Alzheimer’s disease based on biomarkers. The Lancet Neurology, 16(8), 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 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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