Methodological framework description

2017 Adaptation from Oncology:

Boccardi M, Gallo V, Yasui Y, Vineis P, Padovani A, Mosimann U, Giannakopoulos P, Gold G, Dubois B, Jack CR Jr, Winblad B, Frisoni GB, Albanese E; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. The biomarker-based diagnosis of Alzheimer's disease. 2-lessons from oncology. Neurobiol Aging. 2017;52:141-152.

2020 Update:

Boccardi M, Dodich A, Albanese E, Gayet-Ageron A, Festari C, Ashton NJ, Bischof GN, Chiotis K, Leuzy A, Wolters EE, Walter MA, Rabinovici GD, Carrillo M, Drzezga A, Hansson O, Nordberg A, Ossenkoppele R, Villemagne VL, Winblad B, Frisoni GB, Garibotto V. The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update. Eur J Nucl Med Mol Imaging. 2021;48(7):2070-2085.

2021 “Correction” to provide a clearer table describing the study designs and critical outcomes for many validation steps:

Boccardi M, Dodich A, Albanese E, Gayet-Ageron A, Festari C, Ashton NJ, Bischof GN, Chiotis K, Leuzy A, Wolters EE, Walter M, Rabinovici GD, Carrillo M, Drzezga A, Hansson O, Nordberg A, Ossenkoppele R, Villemagne VL, Winblad B, Frisoni G, Garibotto V. Correction to: The Strategic Biomarker Roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update. Eur J Nucl Med Mol Imaging. 2021;48(13):4525-4531.

Relevance of the whole initiative:

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 Jr, 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. Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers. Lancet Neurol. 2017;16(8):661-676.

Assessment of the validation status of biomarkers of AD and LBD, 2017
(Special issue “Roadmap to Alzheimer’s Biomarkers in the Clinic”, Neurobiology of Aging 2017:52):

Cerami C, Dubois B, Boccardi M, Monsch AU, Demonet JF, Cappa SF; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. Clinical validity of delayed recall tests as a gateway biomarker for Alzheimer's disease in the context of a structured 5-phase development framework. Neurobiol Aging. 2017;52:153-166.

Chiotis K, Saint-Aubert L, Boccardi M, Gietl A, Picco A, Varrone A, Garibotto V, Herholz K, Nobili F, Nordberg A; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. Clinical validity of increased cortical uptake of amyloid ligands on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase development framework. Neurobiol Aging. 2017;52:214-227.

Ten Kate M, Barkhof F, Boccardi M, Visser PJ, Jack CR Jr, Lovblad KO, Frisoni GB, Scheltens P; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. Clinical validity of medial temporal atrophy as a biomarker for Alzheimer's disease in the context of a structured 5-phase development framework. Neurobiol Aging. 2017;52:167-182.e1.

Sonni I, Ratib O, Boccardi M, Picco A, Herholz K, Nobili F, Varrone A; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. Clinical validity of presynaptic dopaminergic imaging with 123I-ioflupane and noradrenergic imaging with 123I-MIBG in the differential diagnosis between Alzheimer's disease and dementia with Lewy bodies in the context of a structured 5-phase development framework. Neurobiol Aging. 2017;52:228-242.

Garibotto V, Herholz K, Boccardi M, Picco A, Varrone A, Nordberg A, Nobili F, Ratib O; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. Clinical validity of brain fluorodeoxyglucose positron emission tomography as a biomarker for Alzheimer's disease in the context of a structured 5-phase development framework. Neurobiol Aging. 2017;52:183-195.

Mattsson N, Lönneborg A, Boccardi M, Blennow K, Hansson O; Geneva Task Force for the Roadmap of Alzheimer's Biomarkers. Clinical validity of cerebrospinal fluid Aβ42, tau, and phospho-tau as biomarkers for Alzheimer's disease in the context of a structured 5-phase development framework. Neurobiol Aging. 2017;52:196-213.

Assessment of the validation status of biomarkers of tauopathy, 2021
(Special issue: “Topical Issue on Brain Imaging, Including the Special Section: Diagnostic Utility of FDG-PET in Dementia: Literature Evidence and Expert Opinion”, Eur J Nucl Med Mol Imaging 2021:48(7) )

Chiotis K, Dodich A, Boccardi M, Festari C, Drzezga A, Hansson O, Ossenkoppele R, Frisoni G, Garibotto V, Nordberg A. Clinical validity of increased cortical binding of tau ligands of the THK family and PBB3 on PET as biomarkers for Alzheimer's disease in the context of a structured 5-phase development framework. Eur J Nucl Med Mol Imaging. 2021;48(7):2086-2096. [ ]

Wolters EE, Dodich A, Boccardi M, Corre J, Drzezga A, Hansson O, Nordberg A, Frisoni GB, Garibotto V, Ossenkoppele R. Clinical validity of increased cortical uptake of [18F]flortaucipir on PET as a biomarker for Alzheimer's disease in the context of a structured 5-phase biomarker development framework. Eur J Nucl Med Mol Imaging. 2021;48(7):2097-2109.

Bischof GN, Dodich A, Boccardi M, van Eimeren T, Festari C, Barthel H, Hansson O, Nordberg A, Ossenkoppele R, Sabri O, Giovanni BFG, Garibotto V, Drzezga A. Clinical validity of second-generation tau PET tracers as biomarkers for Alzheimer's disease in the context of a structured 5-phase development framework. Eur J Nucl Med Mol Imaging. 2021;48(7):2110-2120.

Ashton NJ, Leuzy A, Karikari TK, Mattsson-Carlgren N, Dodich A, Boccardi M, Corre J, Drzezga A, Nordberg A, Ossenkoppele R, Zetterberg H, Blennow K, Frisoni GB, Garibotto V, Hansson O. The validation status of blood biomarkers of amyloid and phospho-tau assessed with the 5-phase development framework for AD biomarkers. Eur J Nucl Med Mol Imaging. 2021;48(7):2140-2156.

Leuzy A, Ashton NJ, Mattsson-Carlgren N, Dodich A, Boccardi M, Corre J, Drzezga A, Nordberg A, Ossenkoppele R, Zetterberg H, Blennow K, Frisoni GB, Garibotto V, Hansson O. 2020 update on the clinical validity of cerebrospinal fluid amyloid, tau, and phospho-tau as biomarkers for Alzheimer's disease in the context of a structured 5-phase development framework. Eur J Nucl Med Mol Imaging. 2021;48(7):2121-2139.