The recent full approval of the Alzheimer's drug Leqembi and the potential upcoming approval of Eli Lilly's donanemab mark a significant milestone in the treatment of the disease. These medications have been proven to slow the progression of memory loss and the loss of daily functioning associated with Alzheimer's, as CNN reported on July 17.
The Phase 3 clinical trial results presented at the Alzheimer's Association International Conference showcased the effectiveness of donanemab in delaying the disease's progression. Lilly has completed its submission to the US Food and Drug Administration for donanemab and anticipates regulatory action by the end of the year.
In the laboratory of University College London, trials are led by Dr. Catherine Mummery, a doctor of medical sciences.
"In fact, we are planning to start a trial called 'Primary Prevention in People with Genetic Alzheimer's Disease.' They know that they have the mutation, but it will take about 25 years before the first symptoms manifest. Our goal is to determine whether offering them anti-amyloid therapy can prevent the development of the disease. We plan to begin in the next few months, and I think it is truly interesting," says Mummery.
While the drugs represent the first breakthrough in slowing Alzheimer's progression, experts have raised questions about the extent of their benefits. In a series of editorials in the Journal of the American Medical Association, researchers questioned the degree of clinical benefit observed in the trials.
Both Leqembi and donanemab work by targeting and clearing the amyloid protein, a hallmark of Alzheimer's, in the brain. The trial results showed that patients taking these medications experienced a 35% slower disease progression compared to those on a placebo, as measured by the integrated Alzheimer's Disease Rating Scale (iADRS). However, experts have highlighted the comparatively modest clinical effect and the need for more impactful and safer treatments.
The trial also indicated that the benefit was more prominent in patients with low to medium levels of another Alzheimer's-associated protein called tau. Patients in the low/medium tau category experienced a 35% slowing of disease progression on the iADRS scale, equating to a 4.4-month decline delay over the 18-month trial period.
The safety profile of these drugs is a concern, with adverse events such as brain swelling or bleeds observed in some patients. The drugs are administered through intravenous infusion, and infusion reactions can also occur. Additionally, the medications are costly, with Leqembi priced at $26,500 per year.
Experts emphasise the need for longer-term study to assess the drugs' benefits over extended periods. They also stress the importance of addressing issues related to cost, administration complexity, and safety.
Despite these considerations, the approval of these medications provides hope for patients and their families, who previously faced a lack of effective treatment options. The drugs offer the potential to alter the trajectory of the disease and improve outcomes for individuals with Alzheimer's.
Comments (0)