Improving Informed Decision Making Through Real-World Safety Monitoring of New Alzheimer's Treatments
Funded Grant
Overview
Affiliation
View All
Overview
description
PROJECT SUMMARY Nearly 7 million Americans aged 65 and older are living with Alzheimer's Disease. The approval of monoclonal antibodies targeting amyloid plaques-lecanemab and donanemab-by the US Food and Drug Administration marks a groundbreaking advancement in Alzheimer's Disease treatment, offering new hope to patients. While these drugs have the potential to modestly slow disease progression, they carry significant risks, including brain swelling or hemorrhage, known as amyloid-related imaging abnormalities (ARIA). The treatment also imposes a considerable burden to patients and their care partners, including high financial costs, frequent infusions, brain MRI scans, and specialist visits. Furthermore, patients may need to forgo life-saving anticoagulant therapy if they develop acute myocardial infarction or ischemic stroke during treatment, due to the elevated risk of brain hemorrhage from the concurrent use of anticoagulants and the monoclonal antibody. Given these factors, individualized decision-making that balances potential benefits with risks and personal preferences is crucial. However, information on the treatment burden and safety risks of monoclonal antibody therapy remains limited outside of clinical trials. The objective of this research is to generate real-world evidence on the treatment burden and safety of the monoclonal antibody therapy for Alzheimer's Disease and to develop a decision aid. By analyzing the latest Medicare data and Epic Cosmos electronic health records data in near-real-time as new data become available, the researchers will: 1) assess the uptake and treatment burden of monoclonal antibody therapy; 2) conduct pharmacoepidemiologic studies to evaluate its safety risks, including ARIA and the incidence and outcomes of future cardiovascular events during therapy; and 3) develop and refine a decision aid based on a comprehensive synthesis of clinical trial data and real-world evidence. By incorporating multiple rounds of inputs from patients, care partners, and clinicians, the researchers will ensure the decision aid is person-centered. This proposal will offer the first near-real-time, nationwide multi-database evaluation of a high-risk, disease-modifying treatment for Alzheimer's Disease in real-world settings. The timely evidence generated from this research, combined with clinical trial data, will provide a balanced review of the treatment burden and safety profile of the monoclonal antibody therapy. The decision aid developed from this research will be prepared for a future randomized controlled trial to assess its efficacy in enhancing individualized informed decision-making. Ultimately, this proposal is aligned with the National Institute on Aging's strategic goal to improve the health, well-being, and independence of adults as they age.
