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Tokyo (AFP) – Scientists welcomed the results of a clinical trial confirming that a new drug slows cognitive decline in Alzheimer’s patients, but also pointed to sometimes major side effects.
The complete results of this advanced clinical trial (phase III) carried out in nearly 1,800 people for 18 months confirmed a 27% reduction in cognitive impairment in patients who received lecanemab, a drug developed by the Japanese pharmaceutical group Eisai and the American Biogen.
This “statistically significant” ratio between the two groups had already been announced at the end of September.
The detailed results, published on Wednesday November 29 in the specialized magazine ‘New England Journal of Medicine’, also point to side effects, sometimes serious.
In total, 17.3% of patients who received lecanemab suffered cerebral hemorrhages, compared with 9% of patients in the placebo group.
12.6% of patients treated with lecanemab suffered cerebral edema versus only 1.7% in the placebo group.
However, the overall mortality rate is almost the same in the two groups (0.7% in people who received lecanemab, 0.8% for those who received placebo).
“It’s the first drug that offers a real treatment option for people with Alzheimer’s,” said Bart De Strooper, director of Britain’s Institute for Dementia Research.
“Although the clinical benefits seem somewhat limited, it is expected that they will become more evident if the drug is administered for a longer period of time,” he said.
an incurable disease
In Alzheimer’s disease, two key proteins – tau and another called beta-amyloid – gradually accumulate abnormally in the brain, causing brain cell death and brain shrinkage.
This causes memory loss and an increasing inability to perform everyday tasks.
This disease is one of the main public health problems and affects tens of millions of people around the world.
Lecanemab targets amyloid beta protein deposits, but only in the early stages of the disease, which may limit its use, as Alzheimer’s is often diagnosed late.
Another drug against Alzheimer’s from Biogen and Eisai, named Aduhelm (aducanumab), had already raised hopes in 2021. It was the first drug approved in the United States against the disease since 2003.
But Aduhelm also sparked controversy as the drug’s US agency, the FDA, went against the opinion of an expert panel, which had considered that the treatment had not sufficiently demonstrated its efficacy in clinical trials. The FDA later restricted its use.
Several pharmaceutical companies, such as the Swiss giant Roche, have recently failed to find a treatment for Alzheimer’s, which remains incurable for the moment and whose precise causes and mechanisms remain unclear.
Eisai and Biogen’s new drug also does not cure the disease and “there is no accepted definition of clinically significant effects on the cognitive test” that the study authors used, said Tara Spires-Jones, deputy director of the University’s Center for Discovery Brain Sciences. from Edinburgh (Scotland).
“It is not yet certain that the modest reduction (in the rate of cognitive decline) will make a big difference” for patients, and “longer trials will be needed to ensure that the benefits of this treatment outweigh the risks,” added the neuroscientist.
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