HJNO Sep/Oct 2023

HEALTHCARE JOURNAL OF NEW ORLEANS I  SEP / OCT 2023 51 Melissa Brunvoll Marketing Director Assisted Living and Nursing Care Lambeth House benefit in this devastating disease. This confirmatory study verified that it is a safe and effective treatment for patients with Alzheimer’s disease.” While there is still no cure for Alzheim- er’s, the Leqembi Phase 3 clinical trial showed a significant reduction in decline from baseline to the end of the 18-month study in patients that were given the ac- tual drug versus the placebo. Alzheimer’s Association president and CEO, Joanne Pike, said “This treatment, while not a cure, gives people in the early stages of Alzheimer’s disease more time to maintain their independence and do the things they love. While we continue efforts to discover new targets and test new treatments, peo- ple living with this fatal disease deserve the opportunity to discuss and make the choice with their doctor if an FDA-ap- proved treatment is right for them.” The Alzheimer’s Association is urging healthcare providers to talk with their pa- tients about Leqembi as well as the risks and benefits of the treatment. The medica- tion’s high cost ($26,500 annually) and ac- cessibility is a challenge, but now that the drug has received traditional approval, the Centers for Medicare andMedicaid Servic- es (CMS) will begin to reimburse the drug as long as people enroll in a registry that requires physicians to report safety and ef- fectiveness data for the drug. While the need for a registry has been condemned by the Alzheimer’s Associa- tion, it is still a great step forward in pre- ventative treatment. Alvaro Pascual-Le- one, MD, PhD, a professor of neurology at Harvard Medical School, says, “I see this medication as primarily an overdue catalyst for transformational change. De- mentia care right now is not what it should be. It’s reactive—we wait until people have substantial disability because we don’t do any screening ahead of time.” This new medication, coupled with the risk reduc- tion awareness being spread by ADI, can hopefully lower the number of people who are diagnosed with dementia as well as give those who are a longer lifespan, ex- tended independence, and, in turn, more quality time with their loved ones. n REFERENCES 1 Alzheimer’s Disease International. “World Al- zheimer’s Month.” Accessed July 2023. https:// www.alzint.org/get-involved/world-alzheimers- month/ 2 Alzheimer’s Association. “What is Alzheimer’s Disease?” Accessed July 2023. https://www.alz . org/alzheimers-dementia/what-is-alzheimers 3 Alzheimer’s Disease International. “Risk factors and risk reduction.” Accessed July 2023. https:// www.alzint.org/about/risk-factors-risk-reduc- tion/ 4 FDA. “FDA Converts Novel Alzheimer’s Disease Treament to Traditional Approval: Action Fol- lows Confirmatory Trial to Verify Clinical Ben- efit.” News release, July 6, 2023. https://www.fda . gov/news-events/press-announcements/fda- converts-novel-alzheimers-disease-treatment- traditional-approval#:~:text=Leqembi%20is%20 the%20first%20amyloid,pathophysiological%20 feature%20of%20the%20disease 5 Alzheimer’s Association. “Alzheimer’s Associa- tion Welcomes U.S. FDA Traditional Approval of Leqembi: Full Details.” News release, July 6, 2023. https://www.alz.org/news/2023/lecanemab- leqembi-traditional-fda-approval-full 6 Park, A. “There’s Finally a Fully Approved Al- zheimer’s Drug — But Getting It Won’t Be Easy.” Time. July 6, 2023. https://time.com/6292501/ fda-approval-alzheimers-drug-leqembi- lecanemab/ In addition to health-related risk fac- tors, ADI claims that “it is well established that social connectedness reduces the risk of dementia.” As we age, staying socially active is equally as important as staying physically active. Joining a club or mov- ing into a community where activities are readily available can help older adults feel a sense of connectedness and keep them from feeling isolated and alone. All of this can help reduce their risk of dementia. However, ADI notes that behavior changes can be difficult to achieve. Luck- ily, the medical community has made great strides to improve the treatment options available for patients suffering from Al- zheimer’s disease. On July 6, 2023, the U.S. Food and Drug Administration announced that it was granting traditional approval for a new drug indicated to treat adult patients with Alzheimer’s disease. The drug, Leqembi (lecanemab-irmb), is the first amyloid beta-directed antibody to be converted from an accelerated approval to a traditional approval for the treatment of Alzheimer’s disease after completing a highly successful Phase 3 randomized, controlled clinical trial. Leqembi “works by reducing amyloid plaques that form in the brain,” which is a defining pathophysi- ological feature of Alzheimer’s disease. When speaking about the approval, Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research said, “Today’s action is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease has shown clinical