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 |
|---|---|
| Pages (from-to) | 1729-1741 |
| Number of pages | 13 |
| Journal | Alzheimer's & Dementia |
| Volume | 19 |
| Issue number | 5 |
| Early online date | 9 Oct 2022 |
| DOIs | |
| Publication status | Published - May 2023 |
Keywords
- consensus
- Delphi procedure
- etiological diagnosis
- imaging
- major neurocognitive disorder
- MCI
- mild dementia – biomarker
- neurocognitive disorders
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- 10.1002/alz.12798Licence: CC BY-NC-ND
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In: Alzheimer's & Dementia, Vol. 19, No. 5, 05.2023, p. 1729-1741.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - European consensus for the diagnosis of MCI and mild dementia
T2 - 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, Mercè
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 - 2023/5
Y1 - 2023/5
N2 - 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.
AB - 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.
KW - consensus
KW - Delphi procedure
KW - etiological diagnosis
KW - imaging
KW - major neurocognitive disorder
KW - MCI
KW - mild dementia – biomarker
KW - neurocognitive disorders
U2 - 10.1002/alz.12798
DO - 10.1002/alz.12798
M3 - Article
C2 - 36209379
SN - 1552-5260
VL - 19
SP - 1729
EP - 1741
JO - Alzheimer's & Dementia
JF - Alzheimer's & Dementia
IS - 5
ER -