New experimental formula against him Alzheimer’s disease as shown in a small clinical study, it can slow mental decline in patients by 27%. Optimistic news was announced yesterday by the companies that develop and manufacture it. Its high potency indicates that it may be approved for release. US Food and Drug Administration (FDA) at the beginning of the new year.

Japanese pharmaceutical company Eisai and US Biogen said in a statement yesterday that slowing the progression of degenerative brain disease is “statistically very significant” and that the new formulation of lekanemab meets the goals of the final stage of clinical trials.

Clinical Study

The new formula works by limiting beta-amyloid aggregates in the brain, a hallmark of the disease. The results of the clinical study leave no room for doubt, as was the case with the company’s previous similar drug, Aduhelm, which, despite being able to obtain marketing approval, failed to capture the market.

The experimental formula appears to slow down mental decline in patients by 27%.

Jill Rabinovichi, a neuroscientist at the University of California, San Francisco, notes that a 27 percent reduction in cognitive decline is a result that, although not impressive, may improve patients’ quality of life. Other experts, however, believe that in real terms, the rate of decline may be negligible.

The clinical study involved 1800 patients who were in the initial stage of the disease. The final results are expected to be announced in early November at the Alzheimer’s Conference in San Francisco and published in a scientific journal at the same time.

Volunteers were tested in several areas of the brain, such as memory, orientation and problem solving, to assess the deterioration in their mental abilities. In the group that received the new composition, after six months, significantly better results were recorded compared to those who received placebo. Some volunteers who received lecanemab intravenously twice a month experienced side effects such as cerebral swelling and bleeding that are common to all anti-amyloid drugs. The percentage of patients who developed them was in line with what was expected.

Skepticism

Eisai says the clinical study has confirmed the “amyloid hypothesis” that removing plaques may actually slow the progression of Alzheimer’s disease. However, part of the scientific community still doubts this approach, mainly due to unsuccessful attempts to use other formulations.