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VIVA – Alzheimer is a symptom associated with a decline in brain function that affects memory, thinking ability, and mental health. Typically, Alzheimer's disease happens when brain proteins fail to function normally, disrupting the performance of brain cells (neurons).
Recently, scientists are trying to find a new Alzheimer's medicine called Lecanemab. This medicine is a big breakthrough in the decades-long fight against neurological disorders. This potentially disease-changing trial took place in May 2021, but the results were only published on Tuesday, December 13, 2022, in the New England Journal of Medicine through the New York Post.
"This first step is the hardest; I believe it represents the beginning of the end," said Professor John Hardy a group leader at the UK Dementia Research Institute at University College London, describing the promising findings.
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- nypost.com
The results of a Phase 3 trial found that Lecanemab can reduce neurological symptoms in early-stage Alzheimer's patients. Specifically, it was found to slow cognitive and memory decline by about 27% after 18 months, said the drug's developers, Biogen and Eisai.
To test the efficacy of lecanemab, scientists conducted a trial on 1,795 adults, aged 50 to 90 years old who had early Alzheimer's.
Half of the participants were given the dementia drug while the other half were given a placebo. Lecanemab, a monoclonal antibody injected every two weeks, works by clearing the accumulation of amyloid, a toxic plaque in the brain that is believed to cause neurological disorders that can weaken the brain.
At the start of the trial, participants given lecanemab had an amyloid level of 77.92 centiloids - a unit of amyloid that has been measured, compared to 75.03 in the placebo group. Then, after 18 months, the lecanemab group's amyloid level had plummeted by 55.48 centiloids, while their placebo counterparts had increased by 3.64 centiloids, a significant difference.
The results suggest that "lecanemab has the potential to make a clinically meaningful difference for people living with early stages of Alzheimer's disease and their families by slowing cognitive and functional decline," according to Dr. Lynn Kramer, the chief clinical officer of Alzheimer's disease and brain health at Eisai.
However, the trial was not without its caveats, as some participants experienced adverse side effects. One in ten reported suffering from swelling in the brain, called amyloid-associated imaging disorder, known as ARIA, while 1 in 6 had a brain hemorrhage.
While such complications do not mean lecanemab cannot be administered, "it is important to have strict safety monitoring for people receiving lecanemab, and further trials to fully understand and mitigate these risks," John Hardy remarked.
"Patients need to be monitored by MRI. However, this will certainly increase the burden and cost of therapy," added Hardy.
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 treatment of their disease has progressed. Regardless, study researchers concluded that "longer trials are needed to determine the efficacy and safety of lecanemab in early Alzheimer's disease."
Despite the risks, brain experts remain optimistic about lecanemab's potential to reduce cognitive decline caused by Alzheimer's.
"The overall conclusion is very positive. This trial proves that Alzheimer's disease can be treated." Professor Bart De Strooper, director of the UK DRI remarked.
Lecanemab has been granted "priority review" by the US Food and Drug Administration, which means they will decide whether to approve it for public consumption within six months.
