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TOKYO: Experts have hailed the full data showing that a new drug can slow cognitive decline in people with disabilities Alzheimer’s disease Patients, however, warned that the improvements were relatively small and the treatment could have serious side effects.
Preliminary data from the lecanemab trial released in September found that it had slowed cognitive decline increased by 27% over the 18-month period.
Full trial data published in New England Journal of Medicine, illustrates those findings but also raises concerns about the occurrence of “negative effectsIncluding brain hemorrhage and swelling.
The results showed that 17.3% of the patients who were treated with the drug suffered from bleeding in the brain, compared to 9% of those who received the placebo.
And 12.6% of those taking the drug experienced brain swelling, compared to just 1.7% of those taking the placebo.
Deaths were reported at about the same rate in both arms of the drug trial, developed by Biogen and Eisai.
The findings were widely welcomed by researchers and campaigners for patients with the disease, including Bart de Strooper, director of Dementia Research UK.
“This is the first drug that provides a real treatment option for Alzheimer’s patients,” he said.
“While the clinical benefits seem somewhat limited, it can be expected that they will become more pronounced if the drug is taken over a longer period of time.”
Longer experiments needed
In Alzheimer’s disease, two major proteins, tau and beta-amyloid, build up in tangles and sheets, together known as aggregates, causing brain cell death and leading to brain shrinkage.
Lecanemab works by targeting amyloid, and de Strober said the drug has been shown to be effective in getting rid of it but also has “beneficial effects on other hallmarks of Alzheimer’s disease, including tau.”
The Phase III trial involved nearly 1,800 people, divided between those given the drug and a placebo, and lasted more than 18 months.
They were evaluated on a clinical scale for Alzheimer’s patients that measures cognition and function, as well as for changes in amyloid levels and other indicators.
But Tara Spears-Jones, program leader at the Institute for Dementia Research UK, noted that “there is no accepted definition of clinically meaningful effects in the cognitive test they used.”
She added: “It is not yet clear whether a modest reduction in decline would make a significant difference for people with dementia. Longer trials will be needed to ensure that the benefits of this treatment outweigh the risks.”
The drug also only targets those who are in the early stages of the disease with some level of amyloid buildup, which limits the number of people who can use the treatment.
Because Alzheimer’s disease is not always caught quickly, some experts said an overhaul in early diagnosis would be necessary to ensure more people benefit.
“This is not the end of the lekanimab journey – it is being explored in further trials to see how well it works over a longer period of time,” said Richard Oakley, associate director of research at the Alzheimer’s Society.
“Drug safety is critical, and licanimab has had side effects, but these will be looked at closely in decisions about whether or not to approve licanimab, to see if the benefits outweigh the risks,” he said.
Biogen and Eisai previously brought the Alzheimer’s drug Aduhelm to market, but there was significant controversy over the evidence of its success, and its approval led to three high-profile resignations at the FDA.
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