Donanemab Recommendations Offer Guidance for Alzheimer's Treatment
Key Insights
The FDA approved donanemab (Kisulna; Eli Lilly) in July 2024 for early-stage Alzheimer's disease (AD), based on TRAILBLZAERALZ and TRAILBLAZER ALZ2 trial data.
Appropriate Use Recommendations were established to aid clinicians in implementing donanemab treatment, emphasizing safety and effectiveness.
Experts at the CTAD conference highlighted that these guidelines will evolve with more evidence and clinical experience with AD biomarkers and therapies.
Madrid, Spain – At the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference, Alireza Atri, MD, PhD, director of the Banner Sun Health Research Institute, presented recommendations for the appropriate use of donanemab (Kisulna; Eli Lilly) in treating early-stage Alzheimer's disease (AD). The recommendations aim to guide clinicians in implementing the treatment effectively and safely in real-world practice.
The FDA approved donanemab in July 2024, marking a significant advancement in disease-modifying treatments for AD. The approval was based on data from the phase 2 TRAILBLZAERALZ and phase 3 TRAILBLAZER ALZ2 trials. These trials demonstrated that donanemab, an IgG1 monoclonal antibody, effectively removes amyloid plaques (search), a core pathological feature of AD, and significantly impacts the progression of clinical decline.
Appropriate Use Recommendations
The Appropriate Use Recommendations were developed by the AD and Related Disorders Therapeutic Workgroup and invited experts. These recommendations emphasize the importance of individualized clinical judgment and shared decision-making when determining if donanemab therapy is appropriate for a patient. Safety considerations and opportunities for effectiveness are central to these guidelines.
Atri noted that the recommendations will likely evolve as more evidence and clinical experience with novel AD biomarkers and therapies accumulate. The guidelines are intended to provide a framework for clinicians while allowing for flexibility based on individual patient needs and circumstances.
Clinical Implications
During the CTAD conference, Atri discussed the implications of disease-modifying drugs like donanemab on the progression of AD. He highlighted the correlation between amyloid plaque removal and the reduction of clinical decline observed with current AD treatments. Clinicians are advised to consider various factors when deciding if these new AD treatments are appropriate for their patients, including disease stage, biomarker profiles, and overall health status.