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September/October 2024
September/October 2024 Issue Editor’s Note: Another New Drug for Mild Cognitive Impairment and Dementia Last summer, the FDA approved lecanemab, sold as Leqembi, an antiamyloid antibody IV infusion given every two weeks to individuals with mild cognitive impairment or mild dementia resulting from Alzheimer’s disease and demonstrated the presence of brain amyloid. The drug was shown to slow cognitive and functional decline. This summer, in July, the FDA approved the second drug available to patients with early Alzheimer’s disease and those with mild cognitive impairment to slow the decline in memory and cognition—Eli Lilly’s donanemab, sold under the brand name Kisunla. A 76-week, double-blind, placebo-controlled parallel group study of 1,736 people with a mean age of 73 demonstrated the presence of amyloid in the mild cognitive impairment or mild dementia stage of the disease. The results were statistically significant; Kisunla slowed the procession of the disease by roughly 35% based on a clinical dementia rating scale. A monoclonal antibody that’s delivered as an injection about once a month and clears amyloid in the brain, the drug produces results similar to those of leqembi. The most common side effects are headaches, falls, reactions related to the infusion, and amyloid-related imaging abnormalities (ARIA)—a potentially serious temporary swelling in the brain sometimes accompanied by bleeding. A genetic risk factor may make individuals more prone to ARIA. While ARIA doesn’t always result in symptoms, some patients may have dizziness, nausea, seizures, vision changes, and confusion. According to Lilly, the drug will cost $32,000 for a year’s supply, and it’s believed that Medicare will provide coverage. While the cost is significantly less for Kisunla than for Leqembi, Kisunla may prove to be more cost-effective. Unlike Leqembi, which patients must continue to use, the drug maker believes patients will be able to stop Kisunla once the amyloid plaque in the brain regresses, as almost 70% of trial participants did by the study’s end, promising cost savings and less inconvenience for patients. While many hail the new drug as a great leap forward in the treatment of Alzheimer’s, as with Leqembi, there are critics who insist the cost and risks are too great and the benefits too modest, as well as those insisting that targeting amyloid is not alone the key to treating cognitive decline and dementia. As The New York Times reported, Kisunla is “the latest in a novel class of treatments that has been greeted with hope, disappointment, and skepticism.” If you work with patients with mild cognitive impairment or mild dementia resulting from Alzheimer’s disease, we’d like to hear your thoughts about these new treatments. — Kate Jackson |
