European consensus for the diagnosis of MCI and mild dementia: Preparatory phase

Cristina Festari; Federico Massa; Matteo Cotta Ramusino; Federica Gandolfo; Valentina Nicolosi; Stefania Orini; Dag Aarsland; Federica Agosta; Claudio Babiloni; Merce Boada; Barbara Borroni; Stefano Cappa; Bruno Dubois; Kristian S. Frederiksen; Lutz Froelich; Valentina Garibotto; Jean Georges; Alexander Haliassos; Oskar Hansson; Frank Jessen; Anita Kamondi; Roy P. C. Kessels; Silvia Morbelli; John T. O'Brien; Markus Otto; Armand Perret-Liaudet; Francesca B. Pizzini; Craig W. Ritchie; Philip Scheltens; Mathieu Vandenbulcke; Ritva Vanninen; Frans Verhey; Meike W. Vernooij; Tarek Yousry; Wiesje M. Van der Flier; Flavio Nobili; Giovanni B. Frisoni

doi:10.1002/alz.12798

European consensus for the diagnosis of MCI and mild dementia: Preparatory phase

Cristina Festari, Federico Massa, Matteo Cotta Ramusino, Federica Gandolfo, Valentina Nicolosi, Stefania Orini, Dag Aarsland, Federica Agosta, Claudio Babiloni, Merce Boada, Barbara Borroni, Stefano Cappa, Bruno Dubois, Kristian S. Frederiksen, Lutz Froelich, Valentina Garibotto, Jean Georges, Alexander Haliassos, Oskar Hansson, Frank JessenAnita Kamondi, Roy P. C. Kessels, Silvia Morbelli, John T. O'Brien, Markus Otto, Armand Perret-Liaudet, Francesca B. Pizzini, Craig W. Ritchie, Philip Scheltens, Mathieu Vandenbulcke, Ritva Vanninen, Frans Verhey, Meike W. Vernooij, Tarek Yousry, Wiesje M. Van der Flier, Flavio Nobili, Giovanni B. Frisoni

Research output: Contribution to journal › Article › peer-review

Abstract

Introduction
Etiological diagnosis of neurocognitive disorders of middle-old age relies on biomarkers, although evidence for their rational use is incomplete. A European task force is defining a diagnostic workflow where expert experience fills evidence gaps for biomarker validity and prioritization. We report methodology and preliminary results.

Methods
Using a Delphi consensus method supported by a systematic literature review, 22 delegates from 11 relevant scientific societies defined workflow assumptions.

Results
We extracted diagnostic accuracy figures from literature on the use of biomarkers in the diagnosis of main forms of neurocognitive disorders. Supported by this evidence, panelists defined clinical setting (specialist outpatient service), application stage (MCI-mild dementia), and detailed pre-assessment screening (clinical-neuropsychological evaluations, brain imaging, and blood tests).

Discussion
The Delphi consensus on these assumptions set the stage for the development of the first pan-European workflow for biomarkers’ use in the etiological diagnosis of middle-old age neurocognitive disorders at MCI-mild dementia stages.

Highlights
Rational use of biomarkers in neurocognitive disorders lacks consensus in Europe.
A consensus of experts will define a workflow for the rational use of biomarkers.
The diagnostic workflow will be patient-centered and based on clinical presentation.
The workflow will be updated as new evidence accrues.

Original language	English
Journal	Alzheimer's & Dementia: The Journal of the Alzheimer's Association
Early online date	9 Oct 2022
DOIs	https://doi.org/10.1002/alz.12798
Publication status	E-pub ahead of print - 9 Oct 2022

Keywords / Materials (for Non-textual outputs)

consensus
Delphi procedure
etiological diagnosis
imaging
major neurocognitive disorder
MCI
mild dementia
biomarker
neurocognitive disorders

Access to Document

10.1002/alz.12798

Alzheimer s Dementia - 2022 - Festari - European consensus for the diagnosis of MCI and mild dementia Preparatory phaseFinal published version, 2 MBLicence: Creative Commons: Attribution-NonCommercial-NoDerivatives (CC BY-NC-ND)

Cite this

Festari, C., Massa, F., Cotta Ramusino, M., Gandolfo, F., Nicolosi, V., Orini, S., Aarsland, D., Agosta, F., Babiloni, C., Boada, M., Borroni, B., Cappa, S., Dubois, B., Frederiksen, K. S., Froelich, L., Garibotto, V., Georges, J., Haliassos, A., Hansson, O., ... Frisoni, G. B. (2022). European consensus for the diagnosis of MCI and mild dementia: Preparatory phase. Alzheimer's & Dementia: The Journal of the Alzheimer's Association. Advance online publication. https://doi.org/10.1002/alz.12798

@article{146c8c0195c54c02a445dc191221fc1c,

title = "European consensus for the diagnosis of MCI and mild dementia: Preparatory phase",

abstract = "IntroductionEtiological diagnosis of neurocognitive disorders of middle-old age relies on biomarkers, although evidence for their rational use is incomplete. A European task force is defining a diagnostic workflow where expert experience fills evidence gaps for biomarker validity and prioritization. We report methodology and preliminary results.MethodsUsing a Delphi consensus method supported by a systematic literature review, 22 delegates from 11 relevant scientific societies defined workflow assumptions.ResultsWe extracted diagnostic accuracy figures from literature on the use of biomarkers in the diagnosis of main forms of neurocognitive disorders. Supported by this evidence, panelists defined clinical setting (specialist outpatient service), application stage (MCI-mild dementia), and detailed pre-assessment screening (clinical-neuropsychological evaluations, brain imaging, and blood tests).DiscussionThe Delphi consensus on these assumptions set the stage for the development of the first pan-European workflow for biomarkers{\textquoteright} use in the etiological diagnosis of middle-old age neurocognitive disorders at MCI-mild dementia stages.Highlights Rational use of biomarkers in neurocognitive disorders lacks consensus in Europe. A consensus of experts will define a workflow for the rational use of biomarkers. The diagnostic workflow will be patient-centered and based on clinical presentation. The workflow will be updated as new evidence accrues.",

keywords = "consensus, Delphi procedure, etiological diagnosis, imaging, major neurocognitive disorder, MCI, mild dementia, biomarker, neurocognitive disorders",

author = "Cristina Festari and Federico Massa and {Cotta Ramusino}, Matteo and Federica Gandolfo and Valentina Nicolosi and Stefania Orini and Dag Aarsland and Federica Agosta and Claudio Babiloni and Merce Boada and Barbara Borroni and Stefano Cappa and Bruno Dubois and Frederiksen, {Kristian S.} and Lutz Froelich and Valentina Garibotto and Jean Georges and Alexander Haliassos and Oskar Hansson and Frank Jessen and Anita Kamondi and Kessels, {Roy P. C.} and Silvia Morbelli and O'Brien, {John T.} and Markus Otto and Armand Perret-Liaudet and Pizzini, {Francesca B.} and Ritchie, {Craig W.} and Philip Scheltens and Mathieu Vandenbulcke and Ritva Vanninen and Frans Verhey and Vernooij, {Meike W.} and Tarek Yousry and {Van der Flier}, {Wiesje M.} and Flavio Nobili and Frisoni, {Giovanni B.}",

note = "Funding Information: The authors thank Marina Boccardi, German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany, for her contribution during the planning of this initiative. This project received an unrestricted grant from F. Hoffmann‐La Roche Ltd., Biogen International GmbH, Eisai Europe Limited, Life Molecular Imaging GmbH, and OM Pharma Suisse SA. Cristina Festari is supported by the Ricerca Corrente (Italian Ministry of Health). The funding sources had no role in the conception, design, and implementation of the project nor in data collection, data analysis, and interpretation and discussion of the results, and in the decision to submit the paper for publication. Dag Aarsland has received research support and/or honoraria from Astra‐Zeneca, H. Lundbeck, Novartis Pharmaceuticals, Evonik, Roche Diagnostics, and GE Health, and served as paid consultant for H. Lundbeck, Eisai, Heptares, Mentis Cura, Eli Lilly, Cognetivity, Enterin, Acadia, and Biogen. This paper represents independent research partly funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. Federica Agosta has acquired research support (for the institution) from Italian Ministry of Health, AriSLA (Fondazione Italiana di Ricerca per la SLA) and European Research Council. She has served as speaker ans advisory board for Biogen Idec and Roche. Claudio Babiloni has acquired research support (for the institution) from HORIZON 2020 (H2020‐MSCA‐ITN‐2016, Grant Agreement: 721281). He has served has consultant for San Raffaele Cassino (Italy) and Cyclerion Therapeutics, Inc., (Massachusetts, USA). Merc{\`e} Boada has acquired research support (for the institution) from Instituto de Salud Carlos III (CIBERNED), the EU/EFPIA Innovative Medicines Initiative Joint Undertaking, ADAPTED (Grant:115975), from EXIT project, EU Euronanomed3 Program JCT2017 (Grant:AC17/00100), from PREADAPT project. Joint Program for Neurodegenerative Diseases (JPND; Grant: AC19/00097), and from European Marie Sklodowska Curie (grants PI13/02434, PI16/01861 BA19/00020, and PI19/01301); Acci{\'o}n Estrat{\'e}gica en Salud, integrated in the Spanish National RCDCI Plan and financed by Instituto de Salud Carlos III (ISCIII) – Subdirecci{\'o}n General de Evaluaci{\'o}n and the Fondo Europeo de Desarrollo Regional (FEDER – “Una manera de Hacer Europa”), by Fundaci{\'o}n bancaria “La Caixa” and Gr{\'i}fols SA (GR@ACE project). Via institution she has received fees or honoraria from Grifols, Araclon Biotech, Roche, Biogen, Lilly, Merck, Zambon, Nutricia, Servier, and Novo‐Nordisk. For her institution she has served as board membership for Grifols, Roche, Lilly, Araclon Biotech, Merck, Zambon, Biogen, Novo‐Nordisk, Bioiberica, Eisai, Servier, and Schwabe Pharma. Stefano Cappa has received honoraria for lectures or presentations from Roche and Biogen. He has participated (for his institution) on a Data Safety Monitoring Board or Advisory Board for Biogen. Cristina Festari is supported by the Ricerca Corrente (Italian Ministry of Health). Giovanni Frisoni has received grants or contracts (for his institution) from Private Foundation of Geneva University Hospitals: A.P.R.A. – Association Suisse pour la Recherche sur la Maladie d'Alzheimer, Gen{\`e}ve; Fondation Segr{\'e}, Gen{\`e}ve; Ivan Pictet, Gen{\`e}ve; Fondazione Agusta, Lugano; Fondation Chmielewski, Gen{\`e}ve; Fondation Minkoff, Gen{\`e}ve; Race Against Dementia Foundation, London, UK; ROCHE Pharmaceuticals; OM Pharma; EISAI Pharmaceuticals; Biogen Pharmaceuticals; Novo Nordisk. Competitive research projects have been funded by: H2020, Innovative Medicines Initiative (IMI), IMI2, Swiss National Science Foundation, and VELUX Foundation. Via institution he has served as consultant and/or speaker for Biogen, Diadem, Roche, Novo Nordisk. Lutz Froelich has acquired research support from Hummingbird GmbH, Noselab GmbH. He has he has received consultancy/speaker fees from Abbott, Allergan, Axon Neuroscience, Biogen, Eisai, InfectoPharm, MerckSharpe & Dohme, Neurimmun, Novo Nordisk, Roche, Schwabe Pharma. He has served as advisory board memberships for Avanir, Pharmatropix, Forschungszentrum J{\"u}lich, Neuroscios, Novartis and EADC, DGPPN guideline committee, EAN guideline committee. Valentina Garibotto has received funding from the Swiss National Science Foundation (project n. 185028, 188355, and 169876), the Aetas Foundation, the Velux Foundation, the Schmidheiny Foundation and research/teaching support through her institution from Siemens Healthineers, GE Healthcare, Roche, Merck, Cerveau Technologies and Life Molecular Imaging. Jean Georeges has acquired research support (for Alzheimer Europe) from Innovative Medicines Initiatives and EU Health and Research Programmes. The funding of Alzheimer Europe is declared in all transparency on the organisation's website ( https://www.alzheimer‐europe.org/about‐us/governance/finances/financial‐accounts ). Alexander Haliassos has served as treasurer for IFCC EB, as president for GSCC‐CB and is a member of HellasLAB EB. Oskar Hanssons has acquired research support (for the institution) from ADx, AVID Radiopharmaceuticals, Biogen, Eli Lilly, Eisai, Fujirebio, GE Healthcare, Pfizer, and Roche. In the past 2 years, he has received consultancy/speaker fees from Amylyx, Alzpath, BioArctic, Biogen, Cerveau, Fujirebio, Genentech, Novartis, Roche, and Siemens. Roy Kessels received royalities and/or and fees from Hogrefe Test Publishers, Bohn Stafleu Van Loghum, LannooCampus, Taylor & Francis, Benecke Education and RINO, Utrecht Pearson Assessment, and serves as (unpaid) advisory board membership of FESN and Alzheimer Nederland (Netherlands Alzheimer Foundation). Research programs of Tarek Yousry have been funded by Parexel. He has acquired fundings for his Institution from Reta Lila Weston Trust, NIHR UCLH, Wellcome Trust, Muscular Dystrophy Association USA. G.E. has served as (unpaid) advisory board membership for ESNR, BSNR, Erasmus and WFN. Flavio Nobili received consulting fees from GE Healthcare, BIAL, Biogen and Roche and honoraria for lectures from GE Healthcare. He also served as advisory board member for Biogen. John O'Brien has received for his institution consulting fees from Biogen, honoraria from GE Healthcare; he has participated in the data safety monitoring board or advisory board of Eisai, Taurx and Nordisk. Markus Otto has acquired research support from BMBF – FTLD consortium, moodmarker, ALS association and EU – MIRIADE. He has provided scientific advice for Biogen, Axon and Roche and he has developed a patent for Foundation state Baden‐Wuerttemberg. He has had a fiduciary role in FTLD consortium, German Society for CSF diagnostics and neurochemistry, and Society for CSF diagnostics and neurochemistry. Craig Ritchie has received consulting fees or honoraria from Roche, Biogen, Eisai, Sygnature, Actinogen, Eli Lilly, MSD, Signant Heath, and Alchemab. He is the director of the Brain Health Scotland. He has received for his institution Grant Funding to Brain Health Scotland for Investigator Initiated Trial from Biogen. Philip Scheltens has acquired research support from AC Immune, FUJI‐film/Toyama, IONIS, UCB, and Vivoryon. He has served as consultant (via institution) for AC Immune, Alzheon, Brainstorm Cell, Green Valley, ImmunoBrain Checkpoint, Novartis, Novo Nordisk and received fees for the institution as advisory board member for Genentech. He is also an employee of Life Sciences Partners Amsterdam. Research programs of Wiesje van der Flier have been funded by ZonMW, NWO, EU‐FP7, EU‐JPND, Alzheimer Nederland, Hersenstichting CardioVascular Onderzoek Nederland, Health∼Holland, Topsector Life Sciences & Health, stichting Dioraphte, Gieskes‐Strijbis fonds, stichting Equilibrio, Edwin Bouw fonds, Pasman stichting, stichting Alzheimer & Neuropsychiatrie Foundation, Philips, Biogen MA Inc, Novartis‐NL, Life‐MI, AVID, Roche BV, Fujifilm, Combinostics. WF holds the Pasman chair. WF is recipient of ABOARD, which is a public‐private partnership receiving funding from ZonMW (#73305095007) and Health∼Holland, Topsector Life Sciences & Health (PPP‐allowance; #LSHM20106). She is consultant to Oxford Health Policy Forum CIC, Roche, and Biogen MA Inc. She has been an invited speaker at Boehringer Ingelheim, Biogen MA Inc, Danone, Eisai, WebMD Neurology (Medscape), Springer Healthcare. All funding is paid to her institution. Publisher Copyright: {\textcopyright} 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.",

year = "2022",

month = oct,

day = "9",

doi = "10.1002/alz.12798",

language = "English",

journal = "Alzheimer's & Dementia: The Journal of the Alzheimer's Association",

issn = "1552-5260",

publisher = "Wiley",

}

Festari, C, Massa, F, Cotta Ramusino, M, Gandolfo, F, Nicolosi, V, Orini, S, Aarsland, D, Agosta, F, Babiloni, C, Boada, M, Borroni, B, Cappa, S, Dubois, B, Frederiksen, KS, Froelich, L, Garibotto, V, Georges, J, Haliassos, A, Hansson, O, Jessen, F, Kamondi, A, Kessels, RPC, Morbelli, S, O'Brien, JT, Otto, M, Perret-Liaudet, A, Pizzini, FB, Ritchie, CW, Scheltens, P, Vandenbulcke, M, Vanninen, R, Verhey, F, Vernooij, MW, Yousry, T, Van der Flier, WM, Nobili, F & Frisoni, GB 2022, 'European consensus for the diagnosis of MCI and mild dementia: Preparatory phase', Alzheimer's & Dementia: The Journal of the Alzheimer's Association. https://doi.org/10.1002/alz.12798

TY - JOUR

T1 - European consensus for the diagnosis of MCI and mild dementia: Preparatory phase

AU - Festari, Cristina

AU - Massa, Federico

AU - Cotta Ramusino, Matteo

AU - Gandolfo, Federica

AU - Nicolosi, Valentina

AU - Orini, Stefania

AU - Aarsland, Dag

AU - Agosta, Federica

AU - Babiloni, Claudio

AU - Boada, Merce

AU - Borroni, Barbara

AU - Cappa, Stefano

AU - Dubois, Bruno

AU - Frederiksen, Kristian S.

AU - Froelich, Lutz

AU - Garibotto, Valentina

AU - Georges, Jean

AU - Haliassos, Alexander

AU - Hansson, Oskar

AU - Jessen, Frank

AU - Kamondi, Anita

AU - Kessels, Roy P. C.

AU - Morbelli, Silvia

AU - O'Brien, John T.

AU - Otto, Markus

AU - Perret-Liaudet, Armand

AU - Pizzini, Francesca B.

AU - Ritchie, Craig W.

AU - Scheltens, Philip

AU - Vandenbulcke, Mathieu

AU - Vanninen, Ritva

AU - Verhey, Frans

AU - Vernooij, Meike W.

AU - Yousry, Tarek

AU - Van der Flier, Wiesje M.

AU - Nobili, Flavio

AU - Frisoni, Giovanni B.

N1 - Funding Information: The authors thank Marina Boccardi, German Center for Neurodegenerative Diseases (DZNE), Rostock, Germany, for her contribution during the planning of this initiative. This project received an unrestricted grant from F. Hoffmann‐La Roche Ltd., Biogen International GmbH, Eisai Europe Limited, Life Molecular Imaging GmbH, and OM Pharma Suisse SA. Cristina Festari is supported by the Ricerca Corrente (Italian Ministry of Health). The funding sources had no role in the conception, design, and implementation of the project nor in data collection, data analysis, and interpretation and discussion of the results, and in the decision to submit the paper for publication. Dag Aarsland has received research support and/or honoraria from Astra‐Zeneca, H. Lundbeck, Novartis Pharmaceuticals, Evonik, Roche Diagnostics, and GE Health, and served as paid consultant for H. Lundbeck, Eisai, Heptares, Mentis Cura, Eli Lilly, Cognetivity, Enterin, Acadia, and Biogen. This paper represents independent research partly funded by the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. Federica Agosta has acquired research support (for the institution) from Italian Ministry of Health, AriSLA (Fondazione Italiana di Ricerca per la SLA) and European Research Council. She has served as speaker ans advisory board for Biogen Idec and Roche. Claudio Babiloni has acquired research support (for the institution) from HORIZON 2020 (H2020‐MSCA‐ITN‐2016, Grant Agreement: 721281). He has served has consultant for San Raffaele Cassino (Italy) and Cyclerion Therapeutics, Inc., (Massachusetts, USA). Mercè Boada has acquired research support (for the institution) from Instituto de Salud Carlos III (CIBERNED), the EU/EFPIA Innovative Medicines Initiative Joint Undertaking, ADAPTED (Grant:115975), from EXIT project, EU Euronanomed3 Program JCT2017 (Grant:AC17/00100), from PREADAPT project. Joint Program for Neurodegenerative Diseases (JPND; Grant: AC19/00097), and from European Marie Sklodowska Curie (grants PI13/02434, PI16/01861 BA19/00020, and PI19/01301); Acción Estratégica en Salud, integrated in the Spanish National RCDCI Plan and financed by Instituto de Salud Carlos III (ISCIII) – Subdirección General de Evaluación and the Fondo Europeo de Desarrollo Regional (FEDER – “Una manera de Hacer Europa”), by Fundación bancaria “La Caixa” and Grífols SA (GR@ACE project). Via institution she has received fees or honoraria from Grifols, Araclon Biotech, Roche, Biogen, Lilly, Merck, Zambon, Nutricia, Servier, and Novo‐Nordisk. For her institution she has served as board membership for Grifols, Roche, Lilly, Araclon Biotech, Merck, Zambon, Biogen, Novo‐Nordisk, Bioiberica, Eisai, Servier, and Schwabe Pharma. Stefano Cappa has received honoraria for lectures or presentations from Roche and Biogen. He has participated (for his institution) on a Data Safety Monitoring Board or Advisory Board for Biogen. Cristina Festari is supported by the Ricerca Corrente (Italian Ministry of Health). Giovanni Frisoni has received grants or contracts (for his institution) from Private Foundation of Geneva University Hospitals: A.P.R.A. – Association Suisse pour la Recherche sur la Maladie d'Alzheimer, Genève; Fondation Segré, Genève; Ivan Pictet, Genève; Fondazione Agusta, Lugano; Fondation Chmielewski, Genève; Fondation Minkoff, Genève; Race Against Dementia Foundation, London, UK; ROCHE Pharmaceuticals; OM Pharma; EISAI Pharmaceuticals; Biogen Pharmaceuticals; Novo Nordisk. Competitive research projects have been funded by: H2020, Innovative Medicines Initiative (IMI), IMI2, Swiss National Science Foundation, and VELUX Foundation. Via institution he has served as consultant and/or speaker for Biogen, Diadem, Roche, Novo Nordisk. Lutz Froelich has acquired research support from Hummingbird GmbH, Noselab GmbH. He has he has received consultancy/speaker fees from Abbott, Allergan, Axon Neuroscience, Biogen, Eisai, InfectoPharm, MerckSharpe & Dohme, Neurimmun, Novo Nordisk, Roche, Schwabe Pharma. He has served as advisory board memberships for Avanir, Pharmatropix, Forschungszentrum Jülich, Neuroscios, Novartis and EADC, DGPPN guideline committee, EAN guideline committee. Valentina Garibotto has received funding from the Swiss National Science Foundation (project n. 185028, 188355, and 169876), the Aetas Foundation, the Velux Foundation, the Schmidheiny Foundation and research/teaching support through her institution from Siemens Healthineers, GE Healthcare, Roche, Merck, Cerveau Technologies and Life Molecular Imaging. Jean Georeges has acquired research support (for Alzheimer Europe) from Innovative Medicines Initiatives and EU Health and Research Programmes. The funding of Alzheimer Europe is declared in all transparency on the organisation's website ( https://www.alzheimer‐europe.org/about‐us/governance/finances/financial‐accounts ). Alexander Haliassos has served as treasurer for IFCC EB, as president for GSCC‐CB and is a member of HellasLAB EB. Oskar Hanssons has acquired research support (for the institution) from ADx, AVID Radiopharmaceuticals, Biogen, Eli Lilly, Eisai, Fujirebio, GE Healthcare, Pfizer, and Roche. In the past 2 years, he has received consultancy/speaker fees from Amylyx, Alzpath, BioArctic, Biogen, Cerveau, Fujirebio, Genentech, Novartis, Roche, and Siemens. Roy Kessels received royalities and/or and fees from Hogrefe Test Publishers, Bohn Stafleu Van Loghum, LannooCampus, Taylor & Francis, Benecke Education and RINO, Utrecht Pearson Assessment, and serves as (unpaid) advisory board membership of FESN and Alzheimer Nederland (Netherlands Alzheimer Foundation). Research programs of Tarek Yousry have been funded by Parexel. He has acquired fundings for his Institution from Reta Lila Weston Trust, NIHR UCLH, Wellcome Trust, Muscular Dystrophy Association USA. G.E. has served as (unpaid) advisory board membership for ESNR, BSNR, Erasmus and WFN. Flavio Nobili received consulting fees from GE Healthcare, BIAL, Biogen and Roche and honoraria for lectures from GE Healthcare. He also served as advisory board member for Biogen. John O'Brien has received for his institution consulting fees from Biogen, honoraria from GE Healthcare; he has participated in the data safety monitoring board or advisory board of Eisai, Taurx and Nordisk. Markus Otto has acquired research support from BMBF – FTLD consortium, moodmarker, ALS association and EU – MIRIADE. He has provided scientific advice for Biogen, Axon and Roche and he has developed a patent for Foundation state Baden‐Wuerttemberg. He has had a fiduciary role in FTLD consortium, German Society for CSF diagnostics and neurochemistry, and Society for CSF diagnostics and neurochemistry. Craig Ritchie has received consulting fees or honoraria from Roche, Biogen, Eisai, Sygnature, Actinogen, Eli Lilly, MSD, Signant Heath, and Alchemab. He is the director of the Brain Health Scotland. He has received for his institution Grant Funding to Brain Health Scotland for Investigator Initiated Trial from Biogen. Philip Scheltens has acquired research support from AC Immune, FUJI‐film/Toyama, IONIS, UCB, and Vivoryon. He has served as consultant (via institution) for AC Immune, Alzheon, Brainstorm Cell, Green Valley, ImmunoBrain Checkpoint, Novartis, Novo Nordisk and received fees for the institution as advisory board member for Genentech. He is also an employee of Life Sciences Partners Amsterdam. Research programs of Wiesje van der Flier have been funded by ZonMW, NWO, EU‐FP7, EU‐JPND, Alzheimer Nederland, Hersenstichting CardioVascular Onderzoek Nederland, Health∼Holland, Topsector Life Sciences & Health, stichting Dioraphte, Gieskes‐Strijbis fonds, stichting Equilibrio, Edwin Bouw fonds, Pasman stichting, stichting Alzheimer & Neuropsychiatrie Foundation, Philips, Biogen MA Inc, Novartis‐NL, Life‐MI, AVID, Roche BV, Fujifilm, Combinostics. WF holds the Pasman chair. WF is recipient of ABOARD, which is a public‐private partnership receiving funding from ZonMW (#73305095007) and Health∼Holland, Topsector Life Sciences & Health (PPP‐allowance; #LSHM20106). She is consultant to Oxford Health Policy Forum CIC, Roche, and Biogen MA Inc. She has been an invited speaker at Boehringer Ingelheim, Biogen MA Inc, Danone, Eisai, WebMD Neurology (Medscape), Springer Healthcare. All funding is paid to her institution. Publisher Copyright: © 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.

PY - 2022/10/9

Y1 - 2022/10/9

N2 - IntroductionEtiological diagnosis of neurocognitive disorders of middle-old age relies on biomarkers, although evidence for their rational use is incomplete. A European task force is defining a diagnostic workflow where expert experience fills evidence gaps for biomarker validity and prioritization. We report methodology and preliminary results.MethodsUsing a Delphi consensus method supported by a systematic literature review, 22 delegates from 11 relevant scientific societies defined workflow assumptions.ResultsWe extracted diagnostic accuracy figures from literature on the use of biomarkers in the diagnosis of main forms of neurocognitive disorders. Supported by this evidence, panelists defined clinical setting (specialist outpatient service), application stage (MCI-mild dementia), and detailed pre-assessment screening (clinical-neuropsychological evaluations, brain imaging, and blood tests).DiscussionThe Delphi consensus on these assumptions set the stage for the development of the first pan-European workflow for biomarkers’ use in the etiological diagnosis of middle-old age neurocognitive disorders at MCI-mild dementia stages.Highlights Rational use of biomarkers in neurocognitive disorders lacks consensus in Europe. A consensus of experts will define a workflow for the rational use of biomarkers. The diagnostic workflow will be patient-centered and based on clinical presentation. The workflow will be updated as new evidence accrues.

AB - IntroductionEtiological diagnosis of neurocognitive disorders of middle-old age relies on biomarkers, although evidence for their rational use is incomplete. A European task force is defining a diagnostic workflow where expert experience fills evidence gaps for biomarker validity and prioritization. We report methodology and preliminary results.MethodsUsing a Delphi consensus method supported by a systematic literature review, 22 delegates from 11 relevant scientific societies defined workflow assumptions.ResultsWe extracted diagnostic accuracy figures from literature on the use of biomarkers in the diagnosis of main forms of neurocognitive disorders. Supported by this evidence, panelists defined clinical setting (specialist outpatient service), application stage (MCI-mild dementia), and detailed pre-assessment screening (clinical-neuropsychological evaluations, brain imaging, and blood tests).DiscussionThe Delphi consensus on these assumptions set the stage for the development of the first pan-European workflow for biomarkers’ use in the etiological diagnosis of middle-old age neurocognitive disorders at MCI-mild dementia stages.Highlights Rational use of biomarkers in neurocognitive disorders lacks consensus in Europe. A consensus of experts will define a workflow for the rational use of biomarkers. The diagnostic workflow will be patient-centered and based on clinical presentation. The workflow will be updated as new evidence accrues.

KW - consensus

KW - Delphi procedure

KW - etiological diagnosis

KW - imaging

KW - major neurocognitive disorder

KW - MCI

KW - mild dementia

KW - biomarker

KW - neurocognitive disorders

U2 - 10.1002/alz.12798

DO - 10.1002/alz.12798

M3 - Article

SN - 1552-5260

JO - Alzheimer's & Dementia: The Journal of the Alzheimer's Association

JF - Alzheimer's & Dementia: The Journal of the Alzheimer's Association

ER -

European consensus for the diagnosis of MCI and mild dementia: Preparatory phase

Abstract

Keywords / Materials (for Non-textual outputs)

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