According to statistics, the number of people living with Alzheimer’s disease is projected to hit 78 million by 2030 and 139 million by 2050. With 1.55 million global deaths in 2019 attributed to dementia, a form of Alzheimer’s, researchers and organizations are desperately seeking out ways to address this crisis. Unfortunately, there is currently no cure for Alzheimer’s. However, a newly approved drug may help delay the progression of the disease.
Lecanemab: An Alzheimer’s Breakthrough?
The U.S. Food and Drug Administration (FDA) granted accelerated approval to Lecanemab to treat Alzheimer’s disease in its early stages.
“Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones.
This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.” – Dr. Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research.
Lecanemab, which will be available under the name Leqembi, was created as a monoclonal antibody. The drug acts like antibodies in the body, fighting off infection and attacking foreign material. In regards to lecanemab, it was created to attack and target Aβ deposits, which are the biggest precursors to the development of Alzheimer’s disease. As such, a recent study has suggested that lecanemab may be the key to addressing Alzheimer’s disease.
What does the research say?
A study published in the New England Journal of Medicine shared the full findings of Eisai’s Phase 3 Clarity AD clinical trial for lecanemab’s efficacy in slowing the clinical progression of Alzheimer’s.
The clinical trials consisted of 1795 adults, aged 50 to 90, who suffered from early Alzheimer’s. Half of the participants received either lecanemab or a placebo. The researchers also conducted assessments of cognitive and functional skills both before the trial began, and 18 months later. Lastly, the participants underwent PET scans, in which the researchers checked for the presence of amyloid.
Participants who took lecanemab slowed down their cognitive decline by 27% compared to those who took the placebo. Participants were also 31% less likely to advance to the next stage of Alzheimer’s during the study.
A risk worth taking?
As promising as these findings are, drugs that target amyloid deposits do come with side effects, and lecanemab is not exempt from this.
14% of patients who took lecanemab experienced micro bleeding in the brain. Also, 12.6% of patients who took lecanemab experienced mild swelling in the brain. That said, Dr. Emer MacSweeney, principal investigator of the trial, said that these abnormalities were asymptomatic (were not felt by patients) and were detected by MRI.
Speaking to Medical News Today, Dr. Verna Porter, a neurologist, and director of a neurodegenerative program at Providence Saint John’s Health Center said that these side effects are treatable if the medication that causes it is stopped or the dose reduced.
That said, it’s not just these side effects that are gaining attention in the news.
A recent article published by Science reported on a second death linked to lecanemab. The deceased, a 65-year-old woman, had reportedly received infusions of lecanemab during a clinical trial. Unfortunately, SHE experienced a stroke before passing away from a brain hemorrhage.
Eisai released a statement saying the deaths can’t be attributed to lecanemab as the deceased were also taking blood-thinning medications for other health problems.
How do the experts feel?
Joanne Pike is the President and CEO of the Alzheimer’s Association, and she welcomed the FDA’s decision. She said that by slowing the progression of the disease, individuals will have more time to participate in normal life,
“This could mean more months of recognizing their spouse, children, and grandchildren. This could also mean more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.” Pike added.
Additionally, Sharon Cohen, a neurologist, and director of the Toronto Memory Program echoed these statements. Speaking to the Advisory Board, Cohen said that patients taking lecanemab may be able to recognize loved ones, stay active, or perform everyday tasks longer.
Experts are concerned
However, experts do warn against viewing lecanemab as a cure for Alzheimer’s disease. Joy Snider is a professor of neurology at Washington University School of Medicine. She pointed out that lecanemab is neither a cure nor does it make people get better. Rather, it slows down the progression in very mild disease.
Experts have also raised concerns about the drug’s price tag. Eisai officials SHARED that the fee for the drug will be $26,500 per year for biweekly dosing.
Speaking on lecanemab, Matthew Schrag, a neurology researcher at Vanderbilt University, queried whether the drug’s effectiveness was worth its high price,
“This is really quite a small effect and probably below the threshold of what we’d call clinically significant. … Is this slight, measurable benefit worth the hefty price tag and the side effects patients may experience? I have pretty serious doubts.”
Schrag is not the only one concerned about the benefits of the drug outweighing its high price. Medicare, a federal health insurance program for people 65 or older, revealed that they would not cover lecanemab unless the Centers for Medicare and Medicaid Services (CMS) determined that the drug had clearer evidence of helping patients.
That said, Eisai revealed that it has plans to establish a patient assistance program to provide lecanemab at no cost.
Could Alzheimer’s be a distant memory?
The findings highlighting lecanemab’s effectiveness do look promising, but that doesn’t mean that Alzheimer’s is a thing of the past. Yes, any delay in cognitive decline can be a win for patients and their families.
As we wait to see the outcome of the FDA’s accelerated approval of lecanemab, we can only hope that researchers are inspired enough to continue to find ways to develop drug interventions that will help to treat Alzheimer’s disease.
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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. (2022). Lecanemab in Early Alzheimer’s Disease. The New England journal of medicine, 10.1056/NEJMoa2212948. Advance online publication. https://doi.org/10.1056/NEJMoa2212948