Spillover: The Approval of New Medications for Alzheimer’s Disease Dementia Will Impact Biomarker Disclosure Among Asymptomatic Research Participants

Article type: Review Article

Authors: Mozersky, Jessica^{a; *} | Roberts, J. Scott^b | Rumbaugh, Malia^c | Chhatwal, Jasmeer^d | Wijsman, Ellen^{e; f} | Galasko, Douglas^g | Blacker, Deborah^{h; i} | on behalf of AGREED¹

Affiliations: [a] Bioethics Research Center, Division of General Medical Sciences, Washington University School of Medicine, St.Louis, MO, USA | [b] Department of Health Behavior & Health Education, University of Michigan School of Public Health, Ann Arbor, MI, USA | [c] Department of Medical and Molecular Genetics, Indiana University School of Medicine, Indianapolis, IN, USA | [d] Massachusetts General Hospital and Brigham and Women’s Hospitals, Harvard Medical School, Boston, MA, USA | [e] Department of Medicine, Division of Medical Genetics, University of Washington, Seattle, WA, USA | [f] Department of Biostatistics, University of Washington, Seattle, WA, USA | [g] Department of Neurosciences and ADRC, University of California San Diego, San Diego, CA, USA | [h] Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA | [i] Department of Epidemiology, Harvard T. H. Chan School of Public Health, Boston, MA, USA

Correspondence: [*] Correspondence to: Jessica Mozersky, PhD, Assistant Professor of Medicine, Bioethics Research Center Department of Medicine, Division of General Medical Sciences, Washington University School of Medicine in St. Louis, Campus Box 8005, 4523 Clayton Avenue, St. Louis, MO 63110, USA. Tel.: +1 314 747 3534; E-mail: [email protected].

Note: [1] Advisory Group on Risk Evidence Education for Dementia www.agreedementia.org.

Abstract: In this article we address how the recent, and anticipated upcoming, FDA approvals of novel anti-amyloid medications to treat individuals with mild Alzheimer’s disease (AD) dementia could impact disclosure of biomarker results among asymptomatic research participants. Currently, research is typically the context where an asymptomatic individual may have the option to learn their amyloid biomarker status. Asymptomatic research participants who learn their amyloid status may have questions regarding the meaning of this result and the implications for accessing a potential intervention. After outlining our rationale, we provide examples of how current educational materials used in research convey messages regarding amyloid positivity and the availability of treatments, or lack thereof. We suggest language to improve messaging, as well as strengths of current materials, in addressing these issues for research participants. Although novel medications are currently only approved for use among symptomatic individuals, their availability may have implications for disclosure among asymptomatic research participants with evidence of amyloid deposition, who may be especially interested in information on these interventions for potential prevention, or future treatment, of mild cognitive impairment or dementia due to AD.

Keywords: Alzheimer’s disease, amyloid, asymptomatic disclosure, biomarkers, dementia, new medications, research ethics

DOI: 10.3233/JAD-220113

Journal: Journal of Alzheimer's Disease, vol. 90, no. 3, pp. 1035-1043, 2022