Tokyo – This week, scientists celebrated the results of a clinical trial that confirmed a new drug slows cognitive decline in Alzheimer’s patients, but they also noted some important side effects.
The full results of the advanced (Phase 3) clinical trial in nearly 1,800 people over 18 months confirmed a 27% reduction in cognitive impairment in patients who received lecanemab, a drug developed by the Japanese pharmaceutical group Eisai and American Biogen.
This “statistically significant” relationship between the two groups was already announced at the end of September.
However, the findings, published Wednesday (30) in the New England Journal of Medicine, also point to side effects, sometimes serious.
Overall, 17.3% of patients treated with lecanemab experienced bleeding in the brain, compared to 9% of patients in the placebo group.
Moreover, 12.6% of patients treated with lecanemab experienced cerebral edema and only 1.7% in the placebo group.
Despite this, the overall death rate was nearly the same in the two groups (0.7% in people who received licanimab, and 0.8% in those who received placebo).
“It is the first drug to offer a real treatment option for Alzheimer’s patients,” said Bart de Strooper, director of the British Institute for Dementia Research.
“While the clinical benefits appear to be somewhat limited, they are expected to become more pronounced if the drug is given over a longer period of time,” he said.
Incurable disease
In Alzheimer’s disease, two major proteins — tau and another called beta-amyloid — build up abnormally in the brain, causing brain cells to die and the brain to shrink.
This causes memory loss and an increased inability to perform daily tasks.
The disease is a major public health problem and affects more than 40 million people worldwide.
Lecanemab targets deposits of the beta-amyloid protein, but only in the early stages of the disease, which may limit its use, as Alzheimer’s disease is often diagnosed late.
Another Alzheimer’s drug from Biogen and Eisai, called Aduhelm (aducanumab), has already raised hopes for 2021. It was the first drug approved in the United States against the disease since 2003.
But Aduhelm also sparked controversy when the US drug agency, the Food and Drug Administration, opposed the opinion of the expert panel, which found that the treatment had not shown sufficient efficacy in clinical trials. The US Food and Drug Administration subsequently restricted its use.
Several pharmaceutical companies, such as Swiss giant Roche, have recently failed to find a cure for Alzheimer’s disease, which remains incurable and whose exact causes and mechanisms remain unclear.
big difference
said Tara Spears-Jones, deputy director of the Brain Science Discovery Center at the University of Edinburgh (Scotland).
“It is not yet certain that a modest decrease (in the speed of cognitive decline) will make a significant difference” for patients, the neuroscientist added, and “longer trials will be needed to ensure that the benefits of this treatment outweigh the risks.”
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