Browsing by Author "Wijsman, Ellen"

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    Biomarker disclosure protocols in prodromal Alzheimer’s disease clinical trials
    (Wiley, 2023) Rahman-Filipiak, Annalise; Bolton, Corey; Grill, Joshua D.; Rostamzadeh, Ayda; Chin, Nathaniel; Heidebrink, Judith; Getz, Sarah; Fowler, Nicole R.; Rosen, Allyson; Lingler, Jennifer; Wijsman, Ellen; Clark, Lindsay; Advisory Group on Risk Evidence Education in Dementia (AGREED); Medicine, School of Medicine
    Introduction: The development of biomarkers for Alzheimer's disease (AD) has allowed researchers to increase sample homogeneity and test candidate treatments earlier in the disease. The integration of biomarker "screening" criteria should be met with a parallel implementation of standardized methods to disclose biomarker testing results to research participants; however, the extent to which protocolized disclosure occurs in trials is unknown. Methods: We reviewed the literature to identify prodromal AD trials published in the past 10 years. From these, we quantified the frequency of biomarker disclosure reporting and the depth of descriptions provided. Results: Of 30 published trials using positron emission tomography or cerebrospinal fluid-based amyloid positivity as an eligibility criterion, only one mentioned disclosure, with no details on methods. Discussion: Possible reasons for and implications of this information gap are discussed. Recommendations are provided for trialists considering biomarker screening as part of intervention trials focused on prodromal AD. Highlights: Few prodromal Alzheimer's disease (AD) trial papers discuss biomarker disclosure. Disclosure has implications for participants, family members, and trial success. Disclosure must be consistently integrated and reported in prodromal AD trials. Best practice guidelines and training resources for disclosure are needed.
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    Spillover: The Approval of New Medications for Alzheimer's Disease Dementia Will Impact Biomarker Disclosure Among Asymptomatic Research Participants
    (IOS Press, 2022) Mozersky, Jessica; Roberts, J. Scott; Rumbaugh, Malia; Chhatwal, Jasmeer; Wijsman, Ellen; Galasko, Douglas; Blacker, Deborah; AGREED; Medical and Molecular Genetics, School of Medicine
    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.