The biomarker-based diagnosis of Alzheimer's disease. 1-ethical and societal issues.
There is great interest in the use of biomarkers to assist in the timely identification of Alzheimer's disease (AD) in individuals with mild symptoms. However, the inclusion of AD biomarkers in clinical criteria poses socioethical challenges. The Geneva Task Force for the Roadmap of Alzheimer's Biomarkers was established to deliver a systematic strategic research agenda (aka roadmap) to promote efficient and effective validation of AD biomarkers and to foster their uptake in clinical practice. In this article, we summarize the workshop discussion of the Geneva Task Force "ethical and societal issues" working group, which comprised bioethicists, clinicians, health economists, and representatives of those affected by AD. The working group identified the following key issues that need to be included in the roadmap: improving access to services through timely diagnosis, the need for a diagnostic research protocol before moving to clinical routine, recruitment in diagnostic research protocols in the absence of effective therapy, respect for the autonomy of the individual with mild cognitive impairment in information and consent process and the right not to know biomarkers results, need for counseling programs, disclosure of the diagnosis in a structured environment and the involvement of family members, health policies including the individuals' views and the protection of their interests, and the economic costs for society.
Bioethics Unit, IRCCS Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy. Electronic address: cporteri@fatebenefratelli.eu.
Corinna
C
Porteri
Department of Psychiatry, WHO Collaborating Centre, University of Geneva, Switzerland.
Emiliano
E
Albanese
Department of Pathology, Faculty of Medicine & Surgery, University of Malta, Malta.
Charles
C
Scerri
Medical & Scientific Relations, Alzheimer's Association, Chicago, IL, USA.
Maria C
MC
Carrillo
Medical & Scientific Relations, Alzheimer's Association, Chicago, IL, USA.
Heather M
HM
Snyder
Alzheimer Association Switzerland, Switzerland.
Birgitta
B
Martensson
National Institute for Health and Care Excellence, London, UK.
Mark
M
Baker
Department of Internal Medicine, Rehabilitation and Geriatrics, University Hospitals of Geneva, Switzerland.
Ezio
E
Giacobini
Laboratory of Neuroimaging and Alzheimer's Epidemiology, IRCCS Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy; LANVIE (Laboratory of Neuroimaging of Aging) - Department of Psychiatry, University of Geneva, Switzerland.
Marina
M
Boccardi
Division of Neurogeriatrics, Department NVS, Center for Alzheimer Research, Karolinska Institutet, Huddinge, Sweden.
Bengt
B
Winblad
LANVIE (Laboratory of Neuroimaging of Aging) - Department of Psychiatry, University of Geneva, Switzerland; Memory Clinic - Department of Internal Medicine, University Hospitals of Geneva, Switzerland.
Giovanni B
GB
Frisoni
Institute for Ethics, History, and the Humanities, Geneva University Medical School, Switzerland.
Samia
S
Hurst
D000544:Alzheimer Disease / Q000175:diagnosis*; D001675:Bioethics; D015415:Biomarkers; D060825:Cognitive Dysfunction / Q000175:diagnosis; D006801:Humans; D066262:Social Norms
D015415:Biomarkers
Alzheimer's disease; Disclosure of diagnosis; Ethics; Informed consent; Mild cognitive impairment; Society