Biomarker-Based Risk Prediction of Alzheimer’s Disease Dementia in Mild Cognitive Impairment: Psychosocial, Ethical, and Legal Aspects

Abstract

Background: Today, a growing number of individuals with mild cognitive impairment (MCI) wish to assess their risk of developing Alzheimer’s disease (AD) dementia. The expectations as well as the effects on quality of life (QoL) in MCI patients and their close others through biomarker-based dementia risk estimation are not well studied. Objective: The PreDADQoL project aims at providing empirical data on effects of such prediction on QoL and at developing an ethical and legal framework of biomarker-based dementia risk estimation in MCI. Methods: In the empirical study, 100 MCI-patients and their close others will be recruited from two sites (Germany and Spain). They receive standardized counselling on cerebrospinal fluid (CSF) biomarker-based prediction of AD dementia and a risk disclosure based on their AD biomarker status. A mixed methods approach will be applied to assess outcomes. Results: The pilot-study yielded a specification of the research topics and newly developed questionnaires for the main assessment. Within this binational quantitative and qualitative study, data on attitudes and expectations toward AD risk prediction, QoL, risk communication, coping strategies, mental health, lifestyle changes, and healthcare resource utilization will be obtained. Together with the normative part of the project, an empirically informed ethical and legal framework for biomarker-based dementia risk estimation will be developed. Conclusion: The empirical research of the PreDADQoL study together with the ethical and legal considerations and implications will help to improve the process of counselling and risk disclosure and thereby positively affect QoL and health of MCI-patients and their close others in the context of biomarker-based dementia risk estimation.

Biomarkers of aging

“…To some extent, the assessment of aging biomarkers or the disclosure of diagnostic results is two-sided. On the one hand, it may provide participants/subjects with opportunities for early management of age-related diseases or life planning as a way to enhance their life quality (Rostamzadeh et al, 2021). On the other hand, the limited options for aging interventions make it possible for relevant disclosures to cause specific psychosocial distress that affects the life quality of participants/subjects and alters their social environment (Paulsen et al, 2013).…”

Risk Disclosure in Prodromal Parkinson's Disease

“…The central principle, that is, the respect for autonomy, can also be found in recommendations for risk disclosure in other neurological diseases. In Alzheimer's disease (AD) especially, research and debate on the ethical aspects of risk disclosure is some way ahead, which opens up the possibility of learning from a comparable situation in which some guidelines already exist, 1‐3,28 although internationally accepted recommendations based on stakeholder involvement and empirical data are still in progress 29,30 . In the first instance, ethical debates on risk disclosure in AD have revealed the necessity of a differentiation between the various states of prognostic certainty.…”

“…In Alzheimer's disease (AD) especially, research and debate on the ethical aspects of risk disclosure is some way ahead, which opens up the possibility of learning from a comparable situation in which some guidelines already exist, [1][2][3]28 although internationally accepted recommendations based on stakeholder involvement and empirical data are still in progress. 29,30 In the first instance, ethical debates on risk disclosure in AD have revealed the necessity of a differentiation between the various states of prognostic certainty. For the preclinical phase of AD, in which individuals do not experience any neuropsychological symptoms, it is known that some individuals with a biomarker constellation suggestive for AD will never develop AD during their lifetime, making it particularly important to consider the potential harms of risk disclosure, especially as this state is mostly diagnosed within clinical studies.…”

Communicating and Using Dementia Risk Evidence

“…Aside from drug therapies, the predictive power of DRE also has the potential to guide clinical practice (e.g., [14]) and social policy [15] as large datasets from populations on US guidelines. Models from outside the US come 126 from excellent guidance [21,22] and examples of 127 clinical trial registries that handle DRE effectively 128 [23,24]. There was also a great example of a survey testing [36] independently and outside the healthcare system.…”