After an 18-month trial, pharmaceutical companies Biogen and Eisai report that results from a new study indicate a new clinical drug called lacanemab could be the next step in helping the Alzheimer's community.
By intervening in the earlier stages of Alzheimer’s, lecanemab — when administered through an IV into the bloodstream biweekly — was shown to stop mental and cognitive decline by 27% in patients, compared to patients who were given the placebo in the same dosage.
Dr. Susan Kohlhaas of Alzheimer’s Research UK told The Guardian that this is the first clinical trial in phase 3 to show a significant change in cognitive decline in a generation, and called it a “historic moment for dementia research.”
What’s the risk? Out of about 1,800 patients who participated in the trial, about 1 in 5 experienced side effects including brain swelling or bleeding, that have occurred with other medications similar to lecanemab.
The new medicine specifically targets amyloid plaques (abnormal clumps in the brain) which are associated with Alzheimer’s disease, along with neurofibrillary tangles (tangled bundles of brain fibers), per the National Institute of Aging.
The New York Times reported that while this is not the first anti-amyloid drug that has been tested, it demonstrates a “relatively low” prevalence of brain swelling or bleeding compared to previous drugs.
How does this help? Michel Vounatsos, CEO of Biogen, said this could slow the progression of the disease and “make a meaningful impact on cognition and function.”
Where will the research go next? “Eisai believes these findings will create new horizons in the diagnosis and treatment of Alzheimer’s disease as well as further activate innovation for new treatment options,” said Eisai CEO Harua Naito.
Long-term effects are still being monitored.
Eisai has applied for accelerated approval by the U.S. Food and Drug Administration and will be approved if the drug is found to have a big enough impact on patients to outweigh the risk, per The New York Times. It is expected that the company should have a decision from the FDA by January 2023, and more detailed numbers will be released in November.
What could the future hold for health care facilities? If the drug is approved by the FDA and is dispersed, it will bring a great demand and could overwhelm clinics and health care facilities in the U.K., Jon Schott of Alzheimer’s Research UK told The Guardian.
“We’re not ready to deliver this at scale and we need to address that now,” he said.
It’s unclear how the potential demand could affect health care facilities in the United States with nurses, doctors and other health care professionals still scrambling from the COVID-19 pandemic.