TY - JOUR
T1 - Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers
AU - Frisoni, Giovanni B.
AU - Boccardi, Marina
AU - Barkhof, Frederik
AU - Blennow, Kaj
AU - Cappa, Stefano
AU - Chiotis, Konstantinos
AU - Demonet, Jean-Francois
AU - Garibotto, Valentina
AU - Giannakopoulos, Panteleimon
AU - Gietl, Anton
AU - Hansson, Oskar
AU - Herholz, Karl
AU - Jack, Clifford R.
AU - Nobili, Flavio
AU - Nordberg, Agneta
AU - Snyder, Heather M.
AU - Ten Kate, Mara
AU - Varrone, Andrea
AU - Albanese, Emiliano
AU - Becker, Stefanie
AU - Bossuyt, Patrick
AU - Carrillo, Maria C.
AU - Cerami, Chiara
AU - Dubois, Bruno
AU - Gallo, Valentina
AU - Giacobini, Ezio
AU - Gold, Gabriel
AU - Hurst, Samia
AU - Loenneborg, Anders
AU - Lovblad, Karl-Olof
AU - Mattsson, Niklas
AU - Molinuevo, Jose-Luis
AU - Monsch, Andreas U.
AU - Mosimann, Urs
AU - Padovani, Alessandro
AU - Picco, Agnese
AU - Porteri, Corinna
AU - Ratib, Osman
AU - Saint-Aubert, Laure
AU - Scerri, Charles
AU - Scheltens, Philip
AU - Schott, Jonathan M.
AU - Sonni, Ida
AU - Teipel, Stefan
AU - Vineis, Paolo
AU - Visser, Pieter Jelle
AU - Yasui, Yutaka
AU - Winblad, Bengt
PY - 2017/8
Y1 - 2017/8
N2 - 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.
AB - 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.
KW - 5-PHASE DEVELOPMENT FRAMEWORK
KW - MILD COGNITIVE IMPAIRMENT
KW - POSITRON-EMISSION-TOMOGRAPHY
KW - CEREBROSPINAL-FLUID BIOMARKERS
KW - CLINICAL VALIDITY
KW - ASSOCIATION WORKGROUPS
KW - NATIONAL INSTITUTE
KW - TAU PATHOLOGY
KW - AMYLOID PET
KW - TASK-FORCE
U2 - 10.1016/S1474-4422(17)30159-X
DO - 10.1016/S1474-4422(17)30159-X
M3 - (Systematic) Review article
SN - 1474-4422
VL - 16
SP - 661
EP - 676
JO - Lancet Neurology
JF - Lancet Neurology
IS - 8
ER -