Written By: Dr. Chad Hensel, PT, DPT, MHS, CSCS
One of the primary characteristics of Alzheimer’s is the build-up of amyloid plaques within the brain tissue. Leqembi works by specifically targeting this amyloid plaque. While various drugs target disease symptoms, Leqembi marks the first time full regulatory approval has been granted to a drug meant to slow the progression of the disease. In its phase 3 clinical trial, 1,795 patients from across the country showing mild cognitive impairment or early-stage disease were examined in a randomized, controlled study. Results showed the disease progression was slowed by 27% at the dosages examined. This positive result needs to be weighed against a couple of drawback areas as well.
Excitement over its effects is tempered by discussion of potential side effects. The FDA is including a “boxed warning”, which is its strongest warning label, over the possibility of seizure or death occurring. In the clinical trials, approximately 12.6% of patients receiving Leqembi developed brain swelling and 17% experience brain bleeds. However, it should be noted that of those that had these side effects that were detected on MRI, only 25% had symptoms.
The other sizable barrier is cost. Leqembi will be delivered by IV infusion every two weeks and comes with an initial price tag of $26,400! With the recent news of full FDA approval, CMS has provided instruction that Medicare will provide coverage. This would mean 80% coverage after the deductible is met, but the 20% remaining co-insurance can still amount to several thousand dollars of out-of-pocket expense. Cost-saving options and need-based solutions are hopefully coming on the horizon.
While not a cure, evidence of Leqembi showing a slowing of the disease progression reaches a monumental breakthrough and beacon of hope to millions of patients.
Want to learn more about Alzheimer’s drugs and other medications/supplements that are designed to help improve physical and cognitive performance? Consider taking my Live CE Webinar on August 18, Medications and Supplements, where we examine multiple medications to identify the side effects that impact our world of Rehabilitation! Can’t attend? There is also an online video option where you can take it on your schedule and at your own pace.
Explore online continuing education courses from Chad below:
Visit summit-education.com for more information.
Food and Drug Administration. fda.gov
Swanson, C. J., Zhang, Y., Dhadda, S., Wang, J., Kaplow, J., Lai, R. Y. K., Lannfelt, L., Bradley, H., Rabe, M., Koyama, A., Reyderman, L., Berry, D. A., Berry, S., Gordon, R., Kramer, L. D., & Cummings, J. L. (2021). A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer’s disease with lecanemab, an anti-Aβ protofibril antibody. Alzheimer’s research & therapy, 13(1), 80. https://doi.org/10.1186/s13195-021-00813-8
Van Dyck, C. H., Swanson, C. J., Aisen, P., Bateman, R. J., Chen, C., Gee, M., Kanekiyo, M., Li, D., Reyderman, L., Cohen, S., Froelich, L., Katayama, S., Sabbagh, M., Vellas, B., Watson, D., Dhadda, S., Irizarry, M., Kramer, L. D., & Iwatsubo, T. (2023). Lecanemab in Early Alzheimer’s Disease. The New England journal of medicine, 388(1), 9–21. https://doi.org/10.1056/NEJMoa2212948
Centers for Medicare and Medicaid Services. cms.gov