An international research group conducting final-stage clinical trials of a new treatment for Alzheimer's disease being developed by major pharmaceutical company Eisai and others confirmed on the 29th that the drug is effective in slowing the progression of symptoms. A paper was published in an American medical journal.
Pharmaceutical giant Eisai, which is conducting final-stage clinical trials of a new drug for Alzheimer's disease, lecanemab, and research groups such as the University of Tokyo and Yale University, announced on the 29th that the American medical magazine "New England Journal of medicine” published the results of the clinical trial.
The clinical trial was conducted in approximately 1,800 early-stage Alzheimer's disease patients aged 50 to 90, divided into a drug-administered group and a placebo-administered group, to determine changes in patients' cognitive function. And so on.
As a result, when comparing one and a half years after the start of drug administration, the group receiving lecanemab reduced cognitive function decline by approximately 27% compared to the group receiving placebo, and the symptoms disappeared. It is said that the effectiveness of slowing the progression has been confirmed.
In addition, the amount of abnormal protein "amyloid β" that accumulates in the brain, which is thought to cause Alzheimer's disease, was also significantly reduced in the drug-administered group.
On the other hand, 17.3% of drug-treated patients reported cerebral hemorrhage and 12.6% reported brain swelling.
This is a higher percentage than patients who received fake medicine, and the research group will continue to confirm long-term safety.
Professor Takeshi Iwatsubo of the University of Tokyo, who was involved in the research, said, "This is an epoch-making result that confirmed a clear effect in delaying the progression of symptoms."
Based on the results of this clinical trial, Eisai plans to apply for approval of the drug from regulatory authorities in the United States, Japan, and the EU by the end of March next year.
Research group ``Possibility to reduce nursing care burden''
The research group also reported the results of this clinical trial at an international conference on Alzheimer's disease held in the United States on the 30th of Japan time.
In the clinical trial, we investigated whether there was any change in the decline in cognitive function between a group administered "lecanemab" and a group administered a placebo.
A detailed analysis of the data showed that the lecanemab group appeared to delay cognitive decline by seven and a half months compared to the placebo group.
In addition, another simulation suggested that administration of lecanemab may extend the duration of Alzheimer's disease in a milder state by 2.5 years to 3 years and 1 month. So, the group says that this may lead to a reduction in the burden of nursing care.
On the other hand, regarding safety, the percentage of people who died during the clinical trial was 0.7% in the lecanemab group and 0.8% in the placebo group, which was almost the same.
A subsequent trial also reported that two of the approximately 1,600 people who received lecanemab died of cerebral hemorrhage, but Eisai said that the two who died originally had serious complications. It is said that "I evaluated that it was not a death due to lecanemab" from the child who had it.
What is “lecanemab”?
Lecanemab has been developed as a treatment for Alzheimer's disease by Eisai, a major pharmaceutical company, in collaboration with the American pharmaceutical company Biogen.
In the brains of patients with Alzheimer's disease, an abnormal protein called "amyloid beta" accumulates, and it is believed that this causes the destruction of nerve cells.
Alzheimer's disease treatments have so far been able to delay the worsening of symptoms by acting on nerve cells, but there are no drugs approved in Japan that suppress the progression of the disease itself.
"Lecanemab" is intended to remove "amyloid β" by binding it to an artificially produced antibody at the stage before it hardens, and is expected to have the effect of preventing the destruction of nerve cells and suppressing the progression of the disease itself. increase.
However, since it is not possible to regenerate damaged nerve cells, it is said that it is important to administer it
at the stage of "mild cognitive impairment" before the onset of symptoms and
at an early stage after the onset.