The Food and Drug Administration ( FDA), a regulatory agency linked to the Department of Health of the United States government, has approved the use of Leqembi, a drug against Alzheimer’s that slows down cognitive decline in patients who are in the early stages of the disease. The study on which the drug’s approval was based involved 1,795 patients with mild cognitive impairment or mild stage dementia and confirmed presence of beta-amyloid pathology.
In addition to Leqembi, Donanemab is another drug that was recently approved and aims to slow the
progression of the disease. Tânia Ferraz Alves, psychiatrist, director of the hospitalization units and
deputy director of the clinical staff of the Institute of Psychiatry of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo (HC/FMUSP), explains that the drug is used in a treatment called a monoclonal antibody, since, for over 20 years, all drugs were anticholinesterase drugs — used in people who already had Alzheimer’s disease with the aim of slowing down its progression a little, but who had some limitations of use.
Medication and results
“Monoclonal antibodies are from a different group of drugs. They already act on the pathology, removing
the amyloid plaque”, explains Tânia. Thus, the drug acts on the removal of beta-amyloid and studies show that patients who took this medication compared to placebos had almost a 30% reduction in the
progression of the disease in the cognitive part. This data points to the importance of treatment, as
plaque removal is not enough, and clinical observation of the perception of improvement is necessary.
The expert also reinforces that the sooner the disease is identified, the easier the treatment becomes.
Today, the identification of Alzheimer’s still depends on the patient’s cognitive decline, however, a series
of techniques have been developed to detect the disease through biomarkers. “Thus, people who have a
slight decline, but who present these biomarkers before losing their functionality, already know that
there is a picture of cognitive impairment due to Alzheimer’s”, he explains.
Despite being beneficial for these cases, it is important to understand that the use of these drugs is not
free of side problems, since studies have shown that a number of people had an increased risk of brain
bleeding. Thus, the use of this medication follows a follow-up protocol to identify bleeding or risk
changes.
“The disease has been silent for a long time, which is why biomarkers are so important. The earlier I
identify it, the more beneficial the results are and the more the drugs being developed will show a positive response ”, considers Tânia.
Brazil
In Brazil, the National Health Surveillance Agency (Anvisa) has not yet approved the use of this drug, but it is possible to carry out treatment with anticholinesterases through the Unified Health System (SUS), which allows treatment of cases installed safely. The doctor also analyzes that a question between risk and benefit is always placed in the evaluation of application for some treatments.
The biomarkers observed for the identification of Alzheimer’s are still in their infancy, but they represent
a breakthrough in the development of drugs that may have fewer side effects, cost reduction and greater
effectiveness.