Commentary
Video
Author(s):
The director of the Banner Sun Health Research Institute talked about how the newly approved Alzheimer treatments have shown promise in slowing clinical decline, signaling a foundational shift toward disease-modifying therapies that target core biological processes. [WATCH TIME: 5 minutes]
WATCH TIME: 5 minutes
“For the first time, we can show that these drugs affect a core path of biological process in Alzheimer disease by removing amyloid plaques, which significantly impacts the progression of clinical decline.”
In July 2024, the FDA approved donanemab (Kisulna; Eli Lilly), an IgG1 monoclonal antibody, for the treatment of patients with early-stage clinical Alzheimer disease (AD). The approval was supported by data from phase 2 TRAILBLZAERALZ and phase 3 TRAILBLAZER ALZ2 trials that included innovative aspects that may be difficult to replicate in the clinical practice. Following the approval of the therapy, clinicians have highlighted the importance of individualized clinical judgment and shared decision-making in determining whether donanemab therapy is appropriate for any individual patient with AD.
The Appropriate Use Recommendations were established to guide clinicians with the implementation of the treatment in the real-world practice, emphasizing safety considerations and opportunity for effectiveness. These recommendations were developed by the AD and Related Disorders Therapeutic Workgroup and invited experts who reviewed the clinical trial data of donanemab, FDA prescribing information, and other relevant literature. Experts noted that these guidelines will likely evolve over time as more evidence and clinical experience with novel AD biomarkers as well as therapies are accumulated.
This information was given as a late-breaking communications presentation at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 29 to November 1, in Madrid, Spain, by coauthor Alireza Atri, MD, PhD, director of the Banner Sun Health Research Institute, and colleagues. During the conference, Atri sat down with NeurologyLive® to further discuss about the implications of disease-modifying drugs like donanemab on the progression of AD. He also spoke about how amyloid plaque removal and clinical decline reduction correlates with the current AD treatments. Moreover, he talked about the factors clinicians should consider when deciding if these new AD treatments are appropriate for their patients.
Click here for more coverage of CTAD 2024.