Lecanemab, an experimental medication, is receiving attention after clinical trial findings revealed that it appears to reduce the progression of Alzheimer’s disease, marking a significant advancement in the fight against the fatal and progressive condition.
Lecanemab’s manufacturers, Biogen and Eisai, disclosed in September that in their phase 3 clinical trial, it significantly slowed down patients’ cognitive and functional deterioration by 27%. The New England Journal of Medicine has now published the trial’s findings. Lecanemab “reduced indicators of amyloid in early Alzheimer’s disease and resulted in moderately less decrease on measures of cognition and function than placebo,” the study’s authors write in their conclusion. However, they also note that it was “related with side effects.” It had certain undesirable effects that were worth noting (more on those in a moment).
Longer trials are necessary to establish lecanemab’s effectiveness and safety in treating early Alzheimer’s disease, they stated.
According to the Centers for Disease Control and Prevention, there are currently close to 6 million Americans living with Alzheimer’s disease, and this figure is predicted to increase (CDC). There is presently no cure for Alzheimer’s disease, the sixth biggest cause of death in the nation, and it cannot be prevented from progressing to severe stages.
Therefore, lecanemab may or may not be useful in the effort to combat Alzheimer’s disease. Here are the study’s findings along with what medical professionals believe.
What did the research reveal?
The study found that over a 12-month period, there was no appreciable difference in outcomes between lecanemab and a placebo among individuals who participated in the phase 2 clinical trial. After 18 months, the phase 3 trial discovered that lecanameb was related with reduced cognitive deterioration and higher amyloid plaque clearance.
From March 2019 through March 2021, 235 different medical facilities in North America, Europe, and Asia participated in the phase 3 clinical trial. 1,795 persons between the ages of 50 and 90 who had minor cognitive impairment brought on by early Alzheimer’s disease or mild dementia associated with Alzheimer’s disease were enrolled in the study. Lecanemab IV infusions were administered to study participants at random, either in substitution of lecanemab or a placebo, every two weeks.
Both study groups’ individuals started the research with clinical dementia ratings (also known as CDR-SB scores) of about 3.2. (A higher score reflects greater cognitive impairment.) At the conclusion of the 18-month experiment, the score increased by 1.2 points in the lecanemab-treated group and by about 1.7 points in the placebo group.
The trial also monitored average amyloid levels; at the start, the average amyloid level was 77.92 centiloids in the lecanemab group and 75.03 centiloids in the placebo group. The average levels in the lecanemab group decreased to 55.48 centiloids at the trial’s conclusion, but increased by 3.64 centiloids in the placebo group.
According to Christopher H. van Dyck, M.D., director of the Alzheimer’s Disease Research Center at the Yale University School of Medicine and lead study author, “There is a significant unmet need for treatments that can slow the progression of Alzheimer’s disease, since the treatments in use today only provide temporary symptomatic benefit.”
In a statement, the Alzheimer’s Association praised the research and urged the Food and Drug Administration (FDA) to expedite the drug’s approval.
Lecanemab will give patients more time to participate in daily life and live independently, according to peer-reviewed, published results, the statement reads. It might take them several months longer to recognize their spouse, kids, and grandchildren. Treatments for mild cognitive impairment (MCI) brought on by early Alzheimer’s dementia and Alzheimer’s disease itself are just as valuable as those that prolong the lives of people with other terminal illnesses.
What is the side effects of lecanemab?
The side effects of lecanemab are a major source of contention. According to the trial findings, the medication caused “infusion-related reactions” in over 26% of patients and “amyloid-related imaging abnormalities” with edema or effusions (12.6%) (fluid leaking into a body cavity).
Compared to 9% of those who received a placebo, more than 17% of those who took lecanemab experienced brain bleeding. Only around 3% of those using a placebo discontinued their medication due to side effects, compared to nearly 7% of those on lecanemab.
In total, six people in the lecanemab group and seven people in the placebo group died, or 0.7% of lecanemab participants and 0.8% of placebo participants, respectively.
What do doctors think?
According to Jamie Alan, Ph.D., associate professor of pharmacology and toxicology at Michigan State University, “There are currently drugs available for the treatment of Alzheimer’s disease, but they do not modify the disease progression.”
The Ohio State University Wexner Medical Center’s director of the Center for Cognitive and Memory Disorders, Douglas W. Scharre, M.D., said he was “very excited to hear of the positive clinically significant results.” Finally, a little more hope to help those with Alzheimer’s disease, he continues.
Scott Kaiser, M.D., a geriatrician and the director of geriatric cognitive health at Providence Saint John’s Health Center in Santa Monica, California, says, “This is big news.” Lecanemab “clearly demonstrated some benefit, but there are still open questions with risks for patients as to how clinically significant that benefit will be.”
Lecanemab’s side effects have drawn attention, but according to Dr. Scharre, the drug’s overall safety profile is “reasonably good,” and it is “much improved” over aducanumab, a contentious drug that the FDA approved to try to slow the progression of Alzheimer’s disease. “Only 7% of people taking the medication had to stop due to side effects, compared to 3% of people taking a placebo. This indicates that 93% had adequate drug tolerance, according to Dr. Scharre. “In the lecanemab group, there were six fatalities, while there were seven in the placebo group. There is therefore little difference.
Although infusion reactions are the most frequent side effects, according to Alan, “this isn’t particularly bothersome to me, as these occur with other antibody-based therapies,” he continues.
But there is a cost-benefit ratio to take into account, claims Alan. She claims that some of the side effects included brain bleeding, which might cause further cognitive or physical decline.
Dr. Scharre advises patients to start taking lecanemab as soon as possible if it receives FDA approval in the future. Since this medication only benefits people with mild cognitive impairment brought on by Alzheimer’s disease or mild Alzheimer’s dementia, the expert advises that patients see their doctor as soon as they or a member of their family notices a change in their cognition, memory, or thinking over the course of a year. “If people with Alzheimer’s disease are not found in the early stages, they will miss the chance and window for treatment with these drugs because they will be found too late.”
What happens next with lecanemab?
Lecanemab’s manufacturers stated in a press release that they intend to apply for FDA approval of the medication before April 2023. The drug has already received a “priority review” from the FDA, which indicates that the agency wants to take action within the next six months.
Nevertheless, he exhorts people to “focus on prevention,” which includes engaging in regular exercise, eating a healthy diet, and making an effort to control high blood pressure.