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Neurobiol Aging. 2017 Apr;52:141-152. doi: 10.1016/j.neurobiolaging.2017.01.021.

The biomarker-based diagnosis of Alzheimer's disease. 2-lessons from oncology.

Author information

1
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.
2
Centre of Primary Care and Public Health, Queen Mary, University of London, Barts and the London School of Medicine, Blizard Institute, London, UK.
3
School of Public Health, University of Alberta, Alberta, Canada; Department of Epidemiology & Cancer Control, St. Jude Children's Research Hospital, Memphis, TN, USA.
4
School of Public Health, Imperial College London, London, UK.
5
Neurology Unit, Department of Clinical and Experimental Sciences, University Health and Wealth of Brescia, Brescia, Italy.
6
Gerontechnology & Rehabilitation Group, University of Bern, Bern, Switzerland; University Hospital of Old Age Psychiatry and Psychotherapy, University of Bern, Bern, Switzerland.
7
Department of Psychiatry, Faculty of Medicine, University of Geneva, Geneva, Switzerland.
8
Department of Internal Medicine, Rehabilitation and Geriatrics, University Hospitals and University of Geneva, Thônex, Switzerland.
9
Dementia Research Center and Department of Neurology, Salpêtrière University Hospital, Paris University, Paris, France.
10
Department of Radiology, Mayo Clinic, Rochester, MN, USA.
11
Center for Alzheimer Research, Division of Neurogeriatrics, Department of NVS, Karolinska Institutet, Huddinge, Sweden.
12
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.
13
Department of Psychiatry, WHO Collaborating Centre, University of Geneva, Geneva, Switzerland.

Abstract

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.

KEYWORDS:

Alzheimer; Biomarkers; Dementia; Early diagnosis; Methodology; Validation

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