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

Giovanni B. Frisoni; Marina Boccardi; Frederik Barkhof; Kaj Blennow; Stefano Cappa; Konstantinos Chiotis; Jean Francois Démonet; Valentina Garibotto; Panteleimon Giannakopoulos; Anton Gietl; Oskar Hansson; Karl Herholz; Clifford R. Jack; Flavio Nobili; Agneta Nordberg; Heather M. Snyder; Mara Ten Kate; Andrea Varrone; Emiliano Albanese; Stefanie Becker; Patrick Bossuyt; Maria C. Carrillo; Chiara Cerami; Bruno Dubois; Valentina Gallo; Ezio Giacobini; Gabriel Gold; Samia Hurst; Anders Lönneborg; Karl Olof Lovblad; Niklas Mattsson; José Luis Molinuevo; Andreas U. Monsch; Urs Mosimann; Alessandro Padovani; Agnese Picco; Corinna Porteri; Osman Ratib; Laure Saint-Aubert; Charles Scerri; Philip Scheltens; Jonathan M. Schott; Ida Sonni; Stefan Teipel; Paolo Vineis; Pieter Jelle Visser; Yutaka Yasui; Bengt Winblad

doi:https://doi.org/10.1016/S1474-4422(17)30159-X

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

Giovanni B. Frisoni, Marina Boccardi, Frederik Barkhof, Kaj Blennow, Stefano Cappa, Konstantinos Chiotis, Jean Francois Démonet, Valentina Garibotto, Panteleimon Giannakopoulos, Anton Gietl, Oskar Hansson, Karl Herholz, Clifford R. Jack, Flavio Nobili, Agneta Nordberg, Heather M. Snyder, Mara Ten Kate, Andrea Varrone, Emiliano Albanese, Stefanie BeckerPatrick Bossuyt, Maria C. Carrillo, Chiara Cerami, Bruno Dubois, Valentina Gallo, Ezio Giacobini, Gabriel Gold, Samia Hurst, Anders Lönneborg, Karl Olof Lovblad, Niklas Mattsson, José Luis Molinuevo, Andreas U. Monsch, Urs Mosimann, Alessandro Padovani, Agnese Picco, Corinna Porteri, Osman Ratib, Laure Saint-Aubert, Charles Scerri, Philip Scheltens, Jonathan M. Schott, Ida Sonni, Stefan Teipel, Paolo Vineis, Pieter Jelle Visser, Yutaka Yasui, Bengt Winblad

Research output: Contribution to journal › Review article › Academic › peer-review

457 Citations (Scopus)

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.

Original language	English
Pages (from-to)	661-676
Number of pages	16
Journal	The Lancet Neurology
Volume	16
Issue number	8
DOIs	https://doi.org/10.1016/S1474-4422(17)30159-X
Publication status	Published - 1 Aug 2017

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Frisoni, G. B., Boccardi, M., Barkhof, F., Blennow, K., Cappa, S., Chiotis, K., Démonet, J. F., Garibotto, V., Giannakopoulos, P., Gietl, A., Hansson, O., Herholz, K., Jack, C. R., Nobili, F., Nordberg, A., Snyder, H. M., Ten Kate, M., Varrone, A., Albanese, E., ... Winblad, B. (2017). Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers. The Lancet Neurology, 16(8), 661-676. https://doi.org/10.1016/S1474-4422(17)30159-X

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title = "Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers",

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.",

author = "Frisoni, {Giovanni B.} and Marina Boccardi and Frederik Barkhof and Kaj Blennow and Stefano Cappa and Konstantinos Chiotis and D{\'e}monet, {Jean Francois} and Valentina Garibotto and Panteleimon Giannakopoulos and Anton Gietl and Oskar Hansson and Karl Herholz and Jack, {Clifford R.} and Flavio Nobili and Agneta Nordberg and Snyder, {Heather M.} and {Ten Kate}, Mara and Andrea Varrone and Emiliano Albanese and Stefanie Becker and Patrick Bossuyt and Carrillo, {Maria C.} and Chiara Cerami and Bruno Dubois and Valentina Gallo and Ezio Giacobini and Gabriel Gold and Samia Hurst and Anders L{\"o}nneborg and Lovblad, {Karl Olof} and Niklas Mattsson and Molinuevo, {Jos{\'e} Luis} and Monsch, {Andreas U.} and Urs Mosimann and Alessandro Padovani and Agnese Picco and Corinna Porteri and Osman Ratib and Laure Saint-Aubert and Charles Scerri and Philip Scheltens and Schott, {Jonathan M.} and Ida Sonni and Stefan Teipel and Paolo Vineis and Visser, {Pieter Jelle} and Yutaka Yasui and Bengt Winblad",

note = "Publisher Copyright: {\textcopyright} 2017 Elsevier Ltd",

year = "2017",

month = aug,

day = "1",

doi = "https://doi.org/10.1016/S1474-4422(17)30159-X",

language = "English",

volume = "16",

pages = "661--676",

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Frisoni, GB, Boccardi, M, Barkhof, F, Blennow, K, Cappa, S, Chiotis, K, Démonet, JF, Garibotto, V, Giannakopoulos, P, Gietl, A, Hansson, O, Herholz, K, Jack, CR, Nobili, F, Nordberg, A, Snyder, HM, Ten Kate, M, Varrone, A, Albanese, E, Becker, S, Bossuyt, P, Carrillo, MC, Cerami, C, Dubois, B, Gallo, V, Giacobini, E, Gold, G, Hurst, S, Lönneborg, A, Lovblad, KO, Mattsson, N, Molinuevo, JL, Monsch, AU, Mosimann, U, Padovani, A, Picco, A, Porteri, C, Ratib, O, Saint-Aubert, L, Scerri, C, Scheltens, P, Schott, JM, Sonni, I, Teipel, S, Vineis, P, Visser, PJ, Yasui, Y & Winblad, B 2017, 'Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers', The Lancet Neurology, vol. 16, no. 8, pp. 661-676. https://doi.org/10.1016/S1474-4422(17)30159-X

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 - Démonet, 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 - Lönneborg, Anders

AU - Lovblad, Karl Olof

AU - Mattsson, Niklas

AU - Molinuevo, José 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 - 2017/8/1

Y1 - 2017/8/1

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.

UR - http://www.scopus.com/inward/record.url?scp=85023199961&partnerID=8YFLogxK

U2 - https://doi.org/10.1016/S1474-4422(17)30159-X

DO - https://doi.org/10.1016/S1474-4422(17)30159-X

M3 - Review article

C2 - 28721928

SN - 1474-4422

VL - 16

SP - 661

EP - 676

JO - The Lancet Neurology

JF - The Lancet Neurology

IS - 8

ER -

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

Abstract

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