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

Subtitle: Study Protocol of the PreDADQoL Project

Article type: Research Article

Authors: Rostamzadeh, Ayda^{a; 1; *} | Schwegler, Carolin^{b; 1} | Gil-Navarro, Silvia^c | Rosende-Roca, Maitée^c | Romotzky, Vanessa^b | Ortega, Gemma^c | Canabate, Pilar^c | Moreno, Mariola^c | Schmitz-Luhn, Björn^b | Boada, Mercè^{c; g} | Jessen, Frank^{a; d; e} | Woopen, Christiane^{b; f}

Affiliations: [a] Department of Psychiatry and Psychotherapy, Medical Faculty, University of Cologne, Cologne, Germany | [b] Cologne Center for Ethics, Rights, Economics, and Social Sciences of Health (ceres), University of Cologne, Cologne, Germany | [c] Research Center and Memory Clinic, Fundació ACE, Institut Català de Neurociències Aplicades, Universitat Internacional de Catalunya, Barcelona, Spain | [d] German Center for Neurodegenerative Diseases (DZNE), Venusberg Campus 1, Bonn, Germany | [e] Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Cologne, Germany | [f] Institute for the History of Medicine and Medical Ethics, Research Unit Ethics, University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany | [g] Networking Research Center on Neurodegenerative Diseases (CIBERNED), Instituto de Salud Carlos III, Madrid, Spain

Correspondence: [*] Correspondence to: Dr. Ayda Rostamzadeh, MD, Department of Psychiatry and Psychotherapy, University of Cologne, Medical Faculty, Kerpener Straße 62, 50937 Cologne, Germany. Tel.: +49 0221 478 3870; Fax: +49 0221 478 6030; E-mail: [email protected].

Note: [1] These authors contributed equally to this work.

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.

Keywords: Alzheimer’s disease, biomarker, caregiver, dementia, disclosure, ethics, mild cognitive impairment, quality of life, risk

DOI: 10.3233/JAD-200484

Journal: Journal of Alzheimer's Disease, vol. 80, no. 2, pp. 601-617, 2021