Alzheimer’s disease could soon be a distant memory.
A revolutionary new Alzheimer’s drug named lecanemab could mark a major breakthrough in the decades-long battle against the neurological disorder, according to eye-opening Phase 3 trials. The potentially game-changing dry runs transpired in May 2021, but the results were only published Tuesday in the New England Journal of Medicine.
“This first step is the hardest; I truly believe it represents the beginning of the end,” said Professor John Hardy, group leader at University College London’s Dementia Research Institute, while describing the promising findings.
The Phase 3 trial results found that lecanemab significantly mitigated neurological symptoms in patients in the early stages of Alzheimer’s. Specifically, it was found to slow cognitive and memory decline by around 27% after 18 months, developers Biogen and Eisai announced in September.
In order to test lecanemab’s efficacy, scientists had conducted trial runs on 1,795 adults, aged 50 to 90, who suffered from early Alzheimer’s, CNN reported.
Half of the participants were administered the dementia drug while the other half were given a placebo. lecanemab, a monoclonal antibody that’s injected every two weeks, works by clearing the accumulation of amyloid — toxic plaques in the brain that are believed to cause the debilitating neurological disorder.
At the start of the experiment, participants given lecanemab had an amyloid level of 77.92 centiloids — units of amyloid measurement — compared to 75.03 in the placebo group.
After 18 months, the lecanemab group’s amyloid level plummeted by 55.48 centiloids while their placebo-taking counterparts’ increased by 3.64 centiloids — a significant discrepancy.
The results demonstrated that “lecanemab has the potential to make a clinically meaningful difference for people living with the early stages of Alzheimer’s disease and their families by slowing cognitive and functional decline,” according to Dr. Lynn Kramer, chief clinical officer of Alzheimer’s disease and brain health at Eisai, CNN reported.
However, the trial was not without its caveats as some participants experienced adverse side effects. One in 10 reportedly suffered from swelling in the brain — also known as amyloid-related imaging abnormalities (ARIA) — while one in six experienced brain bleeds, according to CNN.
While those complications don’t mean lecanemab can’t be administered, it “will be important to have rigorous safety monitoring in place for people receiving lecanemab, and further trials to fully understand and mitigate this risk,” according to Hardy.
“It [the patient] needs to be monitored by MRI,” Hardy explained. “This increases the burden and expense of the therapy.”
Not to mention that the trial only involved people with early Alzheimer’s, which raises the question of whether patients will be able to access the medication after their disease has already progressed.
Regardless, study researchers concluded that “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”
Despite the risks, brain experts remained optimistic about lecanemab’s potential to alleviate the cognitive decline caused by Alzheimer’s.
“The overall conclusion is extremely positive,” exclaimed Professor Bart De Strooper, director at the University College London’s Dementia Research Institute. “This trial proves that Alzheimer’s disease can be treated.”
Lecanemab has been granted “priority review” by the US Food and Drug Administration, meaning they will decide whether to approve it for public consumption within six months.