The Japanese pharmaceutical company here announced this Wednesday, 28, that the final phase of the study with an experimental drug to treat Alzheimer’s gave positive results to delay the worsening of the disease. According to these preliminary data, there was a 27% reduction in the worsening of symptoms.
The published results came from the clinical trial, the third and final phase of their analysis of the lecanemaba new treatment for neurodegenerative diseases that is being investigated in partnership with the American pharmaceutical biogen. The data have not yet been peer-reviewed or published in scientific journals.
The clinical trial began in March 2019 and involved 1,795 people from JapanUnited States and Europe with cognitive impairment (dementia) or mild early-stage Alzheimer’s with confirmed abnormalities of beta-amyloid (a protein linked to the development of the disease).
Patients were divided into two groups. While members of one received the drug once every two weeks for 18 months, the other group received a placebo, to investigate changes in their cognitive functions.
After a year and a half, the lecanemab-treated group had a 27% reduction in symptom worsening compared with the placebo-treated group. After six months, “treatment showed statistically significant changes” in cognitive evolution, according to the study results. Another trial with 111 patients in the China is already in progress.
The initially positive data also gives Biogen a second chance after the company’s failed attempt with the other drug, Aduhelm. This drug gained regulatory approval last year despite limited scientific evidence of reducing cognitive decline. Later, the drug proved to be a commercial failure.
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Eisai plans to present the findings of its study at the Alzheimer’s Clinical Trials Congress which will be held in the United States from November 29. There, it will review its findings with regulatory authorities to request, before March 2023, the drug’s approval in the US, Japan and Europe.
“A 27% slowdown in deterioration seems like a modest effect, but for Alzheimer’s patients, it could be very significant,” Gil Rabinovici, a neurologist at the University of California, San Francisco, told the American Journal. The Washington Post.
Testing for Aduhelm was terminated before it was completed, and a post-hoc review raised a number of questions. But the Lecanemab study, called Clarity AD, was “completed as per protocol” and shows that “reducing amyloid at this stage can translate to a slowing of clinical decline,” says Rabinovici.
“This is the first drug that has been shown not only to clear the buildup of amyloid protein in the brain, but also to have a small but statistically significant impact on cognitive decline in people with early-stage Alzheimer’s,” said Susan Kohlhaas of Alzheimer’s UK, an organization with based in the UK, specializing in dementia studies.
like the Estadão showed, researchers have expanded their hypotheses to find out who is the main cause of memory loss and the ability to do everyday tasks. New suspects are in the sights of science: it is believed that neuroinflammation, failures in the connection between one neuron and another and even defects in the work of eliminating the “junk” of the brain may be behind Alzheimer’s. /WITH THE NEW YORK TIMES, AFP and EFE