The biomarker-based diagnosis of Alzheimer's disease. 2-lessons from oncology.
Biomarkers for the diagnosis of Alzheimer's disease (AD) are not yet validated for use in clinical settings. We aim to provide a methodological framework for their systematic validation, by reference to that developed for oncology biomarkers. As for this discipline, the steps for the systematic validation of AD biomarkers need to target analytical validity, clinical validity, and clinical utility. However, the premises are different from oncology: the nature of disease (neurodegeneration vs. cancer), the purpose (improve diagnosis in clinically affected vs. screening preclinical individuals), and the target population (mild cognitive impairment patients referring to memory clinics vs. general population) lead to important differences, influencing both the design of validation studies and the use of selected biomarkers. This framework is applied within a wider initiative to assess the current available evidence on the clinical validity of biomarkers for AD, for the final aim to identify gaps and research priorities, and to inform coordinated research efforts boosting AD biomarkers research.
Department of Psychiatry, LANVIE-Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland; Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), IRCCS S.Giovanni di Dio-Fatebenefratelli, Brescia, Italy. Electronic address: mboccardifbf@gmail.com.
Marina
M
Boccardi
Centre of Primary Care and Public Health, Queen Mary, University of London, Barts and the London School of Medicine, Blizard Institute, London, UK.
Valentina
V
Gallo
School of Public Health, University of Alberta, Alberta, Canada; Department of Epidemiology & Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, USA.
Yutaka
Y
Yasui
School of Public Health, Imperial College London, London, UK.
Paolo
P
Vineis
Neurology Unit, Department of Clinical and Experimental Sciences, University Health and Wealth of Brescia, Brescia, Italy.
Alessandro
A
Padovani
Gerontechnology & Rehabilitation Group, University of Bern, Bern, Switzerland; University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.
Urs
U
Mosimann
Department of Psychiatry, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
Panteleimon
P
Giannakopoulos
Department of Internal Medicine, Rehabilitation and Geriatrics, University Hospitals and University of Geneva, Thônex, Switzerland.
Gabriel
G
Gold
Dementia Research Center and Department of Neurology, Salpêtrière University Hospital, Paris University, Paris, France.
Bruno
B
Dubois
Department of Radiology, Mayo Clinic, Rochester, MN, USA.
Clifford R
CR
Jack
Center for Alzheimer Research, Division of Neurogeriatrics, Department of NVS, Karolinska Institutet, Huddinge, Sweden.
Bengt
B
Winblad
Department of Psychiatry, LANVIE-Laboratory of Neuroimaging of Aging, University of Geneva, Geneva, Switzerland; Laboratory of Alzheimer's Neuroimaging and Epidemiology (LANE), IRCCS S.Giovanni di Dio-Fatebenefratelli, Brescia, Italy; Memory Clinic, University Hospitals and University of Geneva, Geneva, Switzerland.
Giovanni B
GB
Frisoni
Department of Psychiatry, WHO Collaborating Centre, University of Geneva, Geneva, Switzerland.
Emiliano
E
Albanese
D000544:Alzheimer Disease / Q000175:diagnosis*; D015415:Biomarkers; D042241:Early Diagnosis; D006801:Humans; D008495:Medical Oncology; D015203:Reproducibility of Results
D015415:Biomarkers
Alzheimer; Biomarkers; Dementia; Early diagnosis; Methodology; Validation