Lecanemab , an experimental drug for Alzheimer’s disease has been shown to significantly reduce cognitive and functional decline. The companies that manufacture the drug, Eisai and Biogen, say in a statement after the results of a trial carried out on 1,800 patients in the early stages of the disease.
The drug, a monoclonal antibody that attacks amyloid plaques in the neurons of patients, was shown to slow the progression of the disease by 27% compared to a placebo, fulfilling the main objective of the study and potentially offering hope to patients and their families desperate for effective treatment. The drug was administered twice per week for a period of 18 months.
Although not a great effect, it is a positive effect
“This means that targeting the amyloid protein is the right direction,” Ronald Petersen, director of the Alzheimer’s Disease Research Center from the Mayo Clinic in Rochester (USA).
“Although it is not a great effect, it is a positive effect,” he added.
Eisai is seeking expedited approval of the drug from US health authorities (FDA), with a decision expected in early January. The company said it will also seek authorization in Japan and Europe before March 31, 2023.
Eisai said in the statement that the trial results prove the theory that removing deposits from a protein called amyloid beta of the brain of people with early Alzheimer’s may slow the progression of the disease. These plaques are characteristic of people with Alzheimer’s, since they prevent the correct connection between neurons and cause their degeneration.
If the drug is finally approved, it would be the second in 20 years, after the approval last year of aducanumab, a monoclonal antibody that at high doses is capable of eliminating plaques of amyloid protein in the brain that have accumulated for years.
However, there are still strong doubts that targeting the amyloid protein in patients’ brains will help slow down cognitive symptoms.
Although amyloid is considered a biomarker of Alzheimer’s because its accumulation in the brain is key, there is very little scientific evidence that its reduction can help patients by relieving memory and thinking problems.
In fact, for more than two decades, clinical trials of other amyloid-lowering drugs have failed to provide evidence that they actually slow cognitive decline.