Operationalizing AD Biomarker Return of Research Results: Methods from the KU ADRC

Area of Science:

• Neuroscience
• Biomarker Research
• Clinical Trials

Background:

• Alzheimer's disease (AD) biomarker implementation presents challenges in managing and returning complex results to research participants.
• Effective communication of multi-modal biomarker data (neuroimaging, fluid, genetics) is crucial for participant understanding and engagement.

Purpose of the Study:

• To detail a structured, participant-centered workflow for managing and returning Alzheimer's disease biomarker results.
• To assess participant and clinician experiences with the return of biomarker results.

Main Methods:

• Developed an automated, interdisciplinary workflow integrating multimodal biomarker data into diagnostic conferences and participant reports.
• Conducted a non-randomized study evaluating participant anxiety, depression, and decision regret post-results return.

Main Results:

• Implemented a scalable workflow using non-proprietary tools with semi-automated data aggregation.
• Observed statistically significant, though clinically uncertain, changes in participant anxiety and depression following biomarker return.

Conclusions:

• Returning Alzheimer's disease biomarker results within a research setting is feasible, scalable, and well-tolerated.
• The developed model offers guidance for broader adoption in future study designs for biomarker management and return of results.