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The shift to focus on prodromal or ‘preclinical’ stages of Alzheimer’s disease is associated with significant ethical challenges, including but not limited to the implications of learning AD risk status (Karlawish 2011). Within the interdisciplinary Ethical, Legal and Social implications workpackage of the European Prevention of Alzheimer’s Dementia (EPAD) project we studied the effect of AD risk disclosure and developed ethics guidelines for the EPAD longitudinal cohort study and subsequent Proof of Concept trial. We used mixed methods. Firstly, we performed a systematic review of the literature on risk disclosure for AD. Secondly, we met several times in person and through teleconferences during 2015 to discuss ethical dilemmas encountered. Thirdly, we conducted pilot qualitative research in the UK and Spain. For this latter, eight focus groups (total n=49) were conducted with participants in cohort studies to explore attitudes, preferences and concerns related to AD risk disclosure. Most studies we found on risk disclosure are performed in the USA. All studies involved APOE genotype risk disclosure. We did not encounter any studies on disclosure of other biomarkers, including CSF-results or neuroimaging results. Although overall disclosure of APOE genotype seems safe, some concerns on the potential impact remain. While developing ethics guidelines, challenges concerned the development of a risk disclosure process across diverse geographical and cultural contexts, with a heterogeneous study population and different biomarkers. Important gaps remain in the evidence related to national and cultural differences in perceptions of AD risk, and differences between genetic and biomarker-based risk information. The focus groups highlighted the importance of providing suggestions for courses of action following disclosure and the role of local primary and secondary care systems in shaping the long-term impact of risk disclosure. Disclosure of APOE seems relatively safe, but no data are available on the consequences of other biomarker disclosure. The combination of a longitudinal cohort study with proof of concept clinical trials poses several ethical challenges. Focus groups suggest a need for a focus on the post-disclosure period.
Richard et al. (Fri,) studied this question.