Stakeholders' Views on Early Diagnosis for Alzheimer's Disease, Clinical Trial Participation and Amyloid PET Disclosure: A Focus Group Study

Detection of Alzheimer's disease (AD) in an early stage is receiving increasing attention for a number of reasons, such as the failure of drug trials in more advanced disease stages, the demographic evolution, the financial impact of AD, and the approval of amyloid tracers for clinical use. Five focus group interviews with stakeholders (healthy elderly, informal caregivers, nursing staff, researchers, and clinicians) were conducted.. The verbatim transcripts were analysed via the Nvivo 11 software. Most stakeholder groups wanted to know their own amyloid PET scan result. However, differences occurred between FGs: two groups (informal caregivers and researchers) wanted to know, whilst in the three other groups (healthy elderly, nursing staff, and clinicians) FG members opted not to know or were still in doubt about their decision. Stakeholders provided insight into their reasons for wanting to know their amyloid PET scan result (e.g., the need for clarity, to inform relatives, to make arrangements), for not wanting to know their result, or why they were in doubt about their decision (e.g., fear of AD, not wanting to burden their social environment). Several advantages (e.g., to know what is going on with their health, to plan for the future) and disadvantages (e.g., absence of a disease modifying treatment, risks when undergoing tests) were mentioned as part of knowing their amyloid PET scan result. Certain considerations were clustered in a grey zone, in between advantage and disadvantage, such as the emotional consequences. Clinicians, researchers, and policymakers ought to be aware of the diversity of reasons for (not) wanting to know their result and how possible benefits and risks can be viewed differently. The current findings are of importance for future early diagnosis and disclosure of results in the research setting.status: publishe

Review of the Ethical Issues of a Biomarker-Based Diagnoses in the Early Stage of Alzheimer's Disease

BACKGROUND: Today, many healthcare or dementia organizations, clinicians, and companies emphasize the importance of detection of Alzheimer's disease in an early phase. This idea has gained considerable momentum due to the development of biomarkers, the recent FDA and EMA approval of three amyloid tracers, and the failure of a number of recent therapeutic trials conducted in the early dementia phase. On the one hand, an early etiological diagnosis can lead to early and more efficacious intervention. On the other hand, it is questioned how early an etiological diagnosis is beneficial to the patient. Here we consider ethical issues related to the process of biomarker testing and the impact on the diagnostic disclosure to patients with mild cognitive impairment due to prodromal Alzheimer's disease. METHODS: A systematic review of the theoretical bioethics literature was performed by using electronic databases. The review was limited to articles published in English between 2003 and 2016. RESULTS: A total of twenty articles were included in our effort to make an analysis of the ethical challenges. One of the biggest challenges was the uncertainty and the predictive value of the biomarker-based diagnosis where patients can be amyloid positive without full certainty whether or when they will develop symptomatic decline due to Alzheimer's disease. Another challenge was the tension between the right to know versus the wish not to know, the limited efficacy of currently available treatment options, and the opportunities and consequences after receiving such an early diagnosis. CONCLUSION: Based on the results and the additional comments in the discussion, several unanswered questions emerged. Therefore, careful consideration of all these ethical issues is required before the disclosure of a biomarker-based diagnosis to the patient with mild cognitive impairment due to Alzheimer's disease.status: publishe