Alzheimer’s currently has no known treatment. With the disease becoming increasingly widespread, the medical community needs treatments for the disease more than ever. However, there are a few FDA-approved medications for the condition aimed at either delaying disease progression or alleviating some symptoms, with more possible treatments — like lecanemab — now in research and development.
Lecanemab’s usage in treating persons with early Alzheimer’s received accelerated approval1 from the U.S. Food and Drug Administration (FDA) on January 6, 2023.
Several specialists have lauded an experimental lecanemab as the cure we have all been waiting for. Is it a game-changer or just another trial? Let us have a look at how it works and what are its side effects.
What is Lecanemab?
The pharmaceutical firms Eisai and Biogen collaborated to create lecanemab, an investigational medication for the treatment of Alzheimer’s.
Lecanemab is a type of medication known as a monoclonal antibody. The human body naturally generates antibodies to protect against infection.
Scientists develop a monoclonal antibody in a lab setting to combat a particular foreign substance in the body known as an antigen. When a monoclonal antibody is introduced into a person’s body, it induces the immune system to eliminate the specific antigen.
According to the researchers, lecanemab can eliminate amyloid plaques more effectively than the anti-amyloid antibodies aducanumab and gantenerumab since it intervenes sooner in the pathological process that causes Alzheimer’s and has fewer side effects. Researchers aim to restore some function and avoid, or dramatically slow down, cognitive decline by removing amyloid plaque from the brain.
Results of Phase 3 of the trial: How effectively does lecanemab work?
Eisai released the complete results of their Phase 3 Clarity AD clinical study for lecanemab at the 15th Clinical Trials on Alzheimer’s Disease (CTAD) conference2 in late November 2022.
Almost 1,800 persons with early Alzheimer’s between 50 and 90 years of age were given lecanemab or a placebo during the clinical trial. Before the trial’s start and 18 months afterward, researchers evaluated the participants on several cognitive and functional abilities. The subjects also underwent PET scans for amyloid examination in their brains.
At the 18-month follow-up, researchers found that participants who took lecanemab lowered their cognitive deterioration by 27% compared to those who received the placebo.
Lecanemab had positive benefits on biomarkers for amyloid, tau, and other pathophysiology parameters, according to the findings of the Clarity clinical study. Lecanemab demonstrated subsequent effects on tau pathology in addition to removing amyloid plaques directly.
Eisai’s Phase 3 confirmatory Clarity AD clinical trial3 of lecanemab has been published in the New England Journal of Medicine4.
Side Effects of Lecanemab
Researchers also identified several possible side effects of lecanemab at the trial’s completion. Although generally well-tolerated, they reported the following side effects:
- Headaches
- An infusion-related reaction (since the drug is administered through intravenous infusion every two weeks)
- Amyloid Related Imaging Abnormality (ARIA)
ARIA is the bleeding or fluid build-up in the brain. When patients did show signs of ARIA, it was typically asymptomatic, meaning they were unaware they had the condition; it only showed in MRI, and in most cases, treatment continued. As a result, the study’s conclusion remained unchanged, and it will not impact the application to the FDA and other regulatory bodies in other countries for a license to sell lecanemab, according to the researchers.
The trial has also reported three deaths linked to lecanemab.
Is Lecanemab a New Hope?
Scientists consider these results the most encouraging in clinical trials investigating Alzheimer’s treatment hitherto. These findings suggest that lecanemab may prolong a person’s capacity to engage in daily activities, maintain independence, and make decisions about their future medical treatment.
Researchers hope that this can be a long-awaited breakthrough in Alzheimer’s research. However, what works statistically does not always work clinically. We will have to wait till the full results of the trial to see if it is really a game changer!
