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Cited by 426Dementia and Cognitive Impairment ResearchAlzheimer's disease research and treatmentsCancer-related cognitive impairment studies

Alzheimer Disease as a Clinical-Biological Construct—An International Working Group Recommendation

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Dubois, Bruno, Villain, Nicolas, Schneider, Lon, Fox, Nick, Campbell, Noll, Galasko, Douglas, Kivipelto, Miia, Jessen, Frank +37 more·2024·JAMA Neurology
DOI 10.1001/jamaneurol.2024.3770PMC PMC12010406
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Abstract

Importance: Since 2018, a movement has emerged to define Alzheimer disease (AD) as a purely biological entity based on biomarker findings. The recent revision of the Alzheimer’s Association (AA) criteria for AD furthers this direction. However, concerns about a purely biological definition of AD being applied clinically, the understanding of AD by society at large, and the translation of blood-based biomarkers into clinical practice prompt these International Working Group (IWG) updated recommendations. Objective: To consider the revised AA criteria and to offer an alternative definitional view of AD as a clinical-biological construct for clinical use. The recommendations of the 2021 IWG diagnostic criteria are updated for further elaborating at-risk and presymptomatic states. Evidence Review: PubMed was searched for articles published between July 1, 2020, and March 1, 2024, using the terms “biomarker” OR “amyloid” OR “tau” OR “neurodegeneration” OR “preclinical” OR “CSF” OR “PET” OR “plasma” AND “Alzheimer’s disease.” The references of relevant articles were also searched. Findings: In the new AA diagnostic criteria, AD can be defined clinically as encompassing cognitively normal people having a core 1 AD biomarker. However, recent literature shows that the majority of biomarker-positive cognitively normal individuals will not become symptomatic along a proximate timeline. In the clinical setting, disclosing a diagnosis of AD to cognitively normal people with only core 1 AD biomarkers represents the most problematic implication of a purely biological definition of the disease. Conclusions and Relevance: The ultimate aim of the field was to foster effective AD treatments, including preventing symptoms and dementia. The approach of diagnosing AD without a clinical and biological construct would be unwarranted and potentially concerning without a clear knowledge of when or whether symptoms will ever develop. It is recommended that those who are amyloid-positive only and, more generally, most biomarker-positive cognitively normal individuals, should not be labeled as having AD. Rather, they should be considered as being at risk for AD. The expansion of presymptomatic AD is viewed as a better diagnostic construct for those with a specific pattern of biomarkers, indicating that they are proximate to the expression of symptoms in the near future.

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  • ApoE genetic testing requires specific consent procedures and may raise ethical and psychological considerations.

    “Genetic testing requires specific consent procedures, may raise ethical and psychological considerations”

    From Plasma ApoE proteotyping for ApoE ε4 stratification in the anti-amyloid therapies era (2026) · cites this paper as [13]

    The societal impact section (page not specified) discusses psychological consequences of an Alzheimer diagnosis in cognitively normal people and says that how amyloid results are disclosed affects patient experience. It does not specify consent procedures for genetic testing or establish that these disclosure concerns apply to ApoE testing in particular. (LLM, conf=0.82)

    Experimental — accuracy not yet measured

  • ApoE genetic testing is often associated with higher costs (typically hundreds of euros) compared with laboratory assays (less than a hundred euros in our setting).

    “is often associated with higher costs (typically in the order of hundreds of euros) and longer turnaround times (from several days to a few months) compared to laboratory assays that can provide results within hours and at substantially lower cost (less than a hundred euros in our setting) [13–15].”

    From Plasma ApoE proteotyping for ApoE ε4 stratification in the anti-amyloid therapies era (2026) · cites this paper as [13]

    The value of biomarkers section discusses validation and reimbursement, and The societal impact compares protein and genetic biomarkers, but neither gives testing prices or turnaround times. Searches for euros, APOE genotyping costs, and turnaround times found no passage supporting the claimed comparison. (LLM, conf=0.76)

    Experimental — accuracy not yet measured

  • ApoE genetic testing is often associated with longer turnaround times (from several days to a few months) compared with laboratory assays that can provide results within hours.

    “longer turnaround times (from several days to a few months) compared to laboratory assays that can provide results within hours”

    From Plasma ApoE proteotyping for ApoE ε4 stratification in the anti-amyloid therapies era (2026) · cites this paper as [13]

    The societal-impact section compares protein and genetic biomarkers, and Panel 1 mentions APOE e4, but neither discusses how long testing takes. Searches for turnaround times, APOE genetic testing, and assay result times found no passage supporting the claimed comparison of days to months versus hours; page numbers were not available in our copy. (LLM, conf=0.74)

    Experimental — accuracy not yet measured

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Cited by

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Authors
Dubois, B., Villain, N., Schneider, L., Fox, N., Campbell, N., Galasko, D., Kivipelto, M., Jessen, F., Hanseeuw, B., Boada, M., Barkhof, F., Nordberg, A., Froelich, L., Waldemar, G., Frederiksen, K. S., Padovani, A., Planche, V., Rowe, C., Bejanin, A., Ibanez, A., Cappa, S., Caramelli, P., Nitrini, R., Allegri, R., Slachevsky, A., de Souza, L. C., Bozoki, A., Widera, E., Blennow, K., Ritchie, C., Agronin, M., Lopera, F., Delano-Wood, L., Bombois, S., Levy, R., Thambisetty, M., Georges, J., Jones, D. T., Lavretsky, H., Schott, J., Gatchel, J., Swantek, S., Newhouse, P., Feldman, H. H., & Frisoni, G. B.
Affiliations
  • Centre National de la Recherche Scientifique (FR)
  • University of Southern California (US)
  • UK Dementia Research Institute (GB)
  • Purdue University West Lafayette (US)
  • University of California San Diego (US)
  • Karolinska University Hospital (SE)
  • University of Cologne (DE)
  • Cliniques Universitaires Saint-Luc (BE)
  • Ace Alzheimer Center Barcelona, Universitat Internacional de Catalunya, Barcelona, Spain
  • UCL Queen Square Institute of Neurology (GB)
  • Heidelberg University (DE)
  • University of Copenhagen (DK)
  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT)
  • The University of Melbourne (AU)
  • Universitat Autònoma de Barcelona (ES)
  • Latin American Institute for Brain Health (BrainLat), Universidad Adolfo Ibanez, Santiago, Chile
  • Istituto Universitario di Studi Superiori di Pavia (IT)
  • Universidade Federal de Minas Gerais (BR)
  • Department of Neurology, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
  • Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (AR)
  • Clínica Alemana (CL)
  • Behavioral and Cognitive Neurology Unit, Faculdade de Medicina, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil
  • University of North Carolina at Chapel Hill (US)
  • San Francisco VA Medical Center (US)
  • Sahlgrenska University Hospital (SE)
  • University of St Andrews (GB)
  • Medical Office for MIND Institute, Miami, Florida
  • Universidad de Antioquia (CO)
  • Veterans Affairs San Diego Healthcare System, San Diego, California
  • Sorbonne Université (FR)
  • Département de Neurologie, Groupe Hospitalier Pitié-Salpêtrière, AP-HP Sorbonne Université, Institute of Memory and Alzheimer’s Disease, Paris, France
  • National Institutes of Health (US)
  • Alzheimer Europe (LU)
  • Mayo Clinic (US)
  • University of California, Los Angeles (US)
  • Michael E. DeBakey VA Medical Center (US)
  • American Association for Geriatric Psychiatry (US)
  • Vanderbilt University (US)
  • University of Geneva (CH)
Corresponding author
Dubois, Bruno
ORCID
Venue
JAMA Neurology
Publisher
American Medical Association (AMA)
Published
2024-12-01
Volume
81
Issue
12
Pages
1304
ISSN
2168-6149 (ISSN-L)
DOI
10.1001/jamaneurol.2024.3770
PMC
PMC12010406
OpenAlex
W4403986853
Cited by
426
References
7
Citations by year
2026: 203 · 2025: 209 · 2024: 14
FWCI
115.21
Type
journal article
Language
en
Open access
Licence
other-oa
Locations
  • JAMA Neurology (publishedVersion)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, other-oa)
  • PubMed Central (acceptedVersion)
  • Carolina Digital Repository (University of North Carolina at Chapel Hill) (submittedVersion)
  • HAL (submittedVersion, other-oa)
  • UCL Discovery (University College London) (submittedVersion)
  • UEF eRepo (University of Eastern Finland) (submittedVersion, other-oa)
  • Pure Amsterdam UMC (submittedVersion, other-oa)
  • Digital Access to Libraries (submittedVersion, other-oa)
  • DZNE Pub (submittedVersion)
  • Universidad de Chile (submittedVersion, cc-by-nc-nd)
  • UNC Libraries
Funders
  • U.S. Department of Veterans Affairs
  • Alzheimer's Association (20-725707, SG-20- 725707)
  • Bristol-Myers Squibb
  • Eli Lilly and Company
  • Sanofi
  • Massachusetts General Hospital
  • Biogen
  • Vanderbilt University
  • McLean Hospital
  • Vanderbilt University Medical Center
  • Prothena
  • Global Brain Health Institute
  • Association de soutien à la Paralysie Supranucléaire Progressive
  • Cerveau Technologies
  • TauRx Pharmaceuticals
  • Alzheimer Society
  • University of St Andrews
  • University College London
  • European Commission (101156500, 101120706, 779237)
  • Trinity College Dublin
  • University of Melbourne
  • Fonds De La Recherche Scientifique - FNRS
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Eisai
  • Novo Nordisk
  • Centre National de la Recherche Scientifique
  • Fundação de Amparo à Pesquisa do Estado de Minas Gerais
  • Universidad de Antioquia
  • Universidade de São Paulo
  • Sahlgrenska Universitetssjukhuset
  • Göteborgs Universitet
  • Universidad de Chile
  • Université de Genève
  • Università degli Studi di Brescia
  • Universidade Federal de Minas Gerais
  • Centre Hospitalier Universitaire de Bordeaux
  • Universitat Autònoma de Barcelona
  • Siemens Healthineers
  • Servier
  • Clínica Alemana de Santiago
  • Grifols
  • Julius Clinical
  • Fleni
  • Agencia Nacional de Investigación y Desarrollo (ACT210096, FONDAP-15150012, 15150012, ANID/FONDAP/15150012, FONDECYT Regular (1210195, 1210195, 1210176, 1220995, 1231839)
  • Fondation pour la Recherche sur Alzheimer
  • National Institutes of Health (R01AG21051, 15150012)
  • University of California, Los Angeles
  • University of North Carolina at Chapel Hill
  • University of California, San Diego
  • University of California, San Francisco
  • Veterans Affairs San Diego Healthcare System
  • Geriatric Research Education and Clinical Center
  • Instituto de Salud Carlos III (CP20/00038, PI22/00307)
  • Sahlgrenska Akademin
  • National Institute on Aging (R01AG057234, P01AG019724, R01AG075775)
  • Fogarty International Center
  • NIH Clinical Center
  • Jane and Terry Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles
  • Fondo de Financiamiento de Centros de Investigación en Áreas Prioritarias (15150012)
  • Cilag
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cancer-related cognitive impairment studies
Keywords
Alzheimer's disease, diagnostic criteria, amyloid biomarkers, tau biomarkers, preclinical Alzheimer's disease, cognitively normal individuals, blood-based biomarkers, clinical translation of biomarkers, neurodegeneration
MeSH terms
Alzheimer Disease, Humans, Biomarkers

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