創薬

科学分野:

• Neuroscience; Genetics; Digital Health

背景:

• The advent of amyloid-modifying therapies necessitates efficient disclosure of Alzheimer's disease (AD) genetic and biomarker results.
• Shortages in genetic counselors and dementia specialists, alongside regulatory requirements, highlight the need for scalable result communication methods.

研究 の 目的:

• To evaluate the non-inferiority of participant-directed digital platforms versus telehealth for disclosing APOE genotype results in Alzheimer's disease (AD).
• To assess the feasibility and acceptance of self-sampling for biomarker testing (plasma pTau-217) in the context of AD risk assessment.

主な方法:

• The eSMARTER trial is a decentralized, randomized study enrolling ~600 adults aged 60-80 with prior APOE testing.
• Participants are randomized to receive APOE results via telehealth or digital platforms (web-based or chatbot), with an option for plasma pTau-217 results.
• Online assessments measure cognitive, affective, and behavioral outcomes; remote phlebotomy is used for blood sample collection.

主要な成果:

• Enrollment for the eSMARTER study commenced in October 2024 and is slated to conclude in February 2025.
• Data on recruitment, screening, enrollment, demographics, and health characteristics will be presented.
• Key insights and lessons learned from implementing a national, decentralized, randomized trial will be shared.

結論:

• The eSMARTER study provides practical, scalable solutions for communicating AD genetic and biomarker results responsibly.
• Developed digital platforms will support healthcare providers in returning AD-related test results in clinical and research settings.
• All collected data and samples will be made publicly available for further research.