4.7 Article

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

Journal

ALZHEIMERS & DEMENTIA
Volume -, Issue -, Pages -

Publisher

WILEY
DOI: 10.1002/alz.12798

Keywords

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

Funding

  1. F. Hoffmann-La Roche Ltd.
  2. Biogen International GmbH
  3. Eisai Europe Limited
  4. Life Molecular Imaging GmbH
  5. OM Pharma Suisse SA
  6. Italian Ministry of Health
  7. Astra-Zeneca
  8. H. Lundbeck
  9. Novartis Pharmaceuticals
  10. Evonik
  11. Roche Diagnostics
  12. GE Health
  13. National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London
  14. AriSLA (Fondazione Italiana di Ricerca per la SLA)
  15. European Research Council
  16. HORIZON 2020 (H2020-MSCA-ITN-2016) [721281]
  17. Instituto de Salud Carlos III (CIBERNED)
  18. EU/EFPIA Innovative Medicines Initiative Joint Undertaking, ADAPTED [115975]
  19. EXIT project, EU Euronanomed3 Program JCT2017 [AC17/00100]
  20. PREADAPT project. Joint Program for Neurodegenerative Diseases (JPND) [AC19/00097]
  21. Accion Estrategica en Salud, integrated in the Spanish National RCDCI Plan
  22. Instituto de Salud Carlos III (ISCIII) -Subdireccion General de Evaluacion
  23. Fondo Europeo de Desarrollo Regional (FEDER -Una manera de Hacer Europa)
  24. Fundacion bancaria La Caixa
  25. Grifols SA (GR@ACEproject)
  26. A.P.R.A. -Association Suisse pour la Recherche sur la Maladie d'Alzheimer, Geneve
  27. Fondation Segre, Geneve
  28. Ivan Pictet, Geneve
  29. Fondazione Agusta, Lugano
  30. Fondation Chmielewski, Geneve
  31. Fondation Minkoff, Geneve
  32. Race Against Dementia Foundation, London, UK
  33. ROCHE Pharmaceuticals
  34. OM Pharma
  35. EISAI Pharmaceuticals
  36. Biogen Pharmaceuticals
  37. Novo Nordisk
  38. H2020, Innovative Medicines Initiative (IMI), IMI2
  39. Swiss National Science Foundation
  40. VELUX Foundation
  41. Hummingbird GmbH
  42. Noselab GmbH
  43. Swiss National Science Foundation [185028, 188355, 169876]
  44. Aetas Foundation
  45. Schmidheiny Foundation
  46. Siemens Healthineers
  47. GE Healthcare
  48. Roche
  49. Merck
  50. Cerveau Technologies
  51. Life Molecular Imaging
  52. Innovative Medicines Initiatives
  53. EU Health and Research Programmes
  54. ADx
  55. AVID Radiopharmaceuticals
  56. Biogen
  57. Eli Lilly
  58. Eisai
  59. Fujirebio
  60. GEHealthcare
  61. Pfizer
  62. Parexel
  63. Reta Lila Weston Trust
  64. NIHR UCLH
  65. Wellcome Trust
  66. Muscular Dystrophy Association USA
  67. BMBF -FTLD consortium
  68. Moodmarker
  69. ALS association
  70. EU -MIRIADE
  71. AC Immune
  72. FUJI-film/Toyama
  73. IONIS
  74. UCB
  75. Vivoryon
  76. ZonMW
  77. NWO
  78. EU-FP7
  79. EUJPND
  80. Alzheimer Nederland
  81. Hersenstichting CardioVascular Onderzoek Nederland
  82. Health similar toHolland, Topsector Life Sciences Health
  83. Stichting Dioraphte
  84. Gieskes-Strijbis fonds
  85. Sichting Equilibrio
  86. Edwin Bouw fonds
  87. Pasman stichting
  88. Stichting Alzheimer & Neuropsychiatrie Foundation
  89. Philips
  90. BiogenMAInc
  91. Novartis-NL
  92. Life-MI
  93. AVID
  94. Roche BV
  95. Fujifilm
  96. Combinostics
  97. Pasman chair
  98. ABOARD from ZonMW [73305095007]
  99. Health similar to Holland, Topsector Life Sciences & Health (PPP-allowance) [LSHM20106]
  100. Universite de Geneve
  101. [PI13/02434]
  102. [PI16/01861 BA19/00020]
  103. [PI19/01301]

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This study developed a pan-European workflow for the etiological diagnosis of neurocognitive disorders in middle-old age based on biomarkers. The workflow was developed through a Delphi consensus method and a systematic literature review, aiming to provide guidance for the rational use of biomarkers in clinical practice.
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.

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