The Food and Drug Administration (FDA) – the US health agency equivalent to Anvisa – approved this month the use of a new drug for the treatment of Alzheimer’s. Lecanemab, which will be marketed under the name Leqembi, is the first drug that has been shown to delay cognitive decline in patients with early and mild disease.
The medicine developed by the Japanese pharmaceutical Eisa in partnership with the American Biogen, is a monoclonal antibody administered by intravenous infusion every two weeks. The companies estimate that patients will have to spend US$ 26,500 a year to follow the treatment, around R$ 135,000.
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Federal District
Alzheimer’s is the dementia that most affects elderly people with caregivers in the DF
It is the first time that a medication acts on the basis of Alzheimer’s, aiming at reducing the amyloid protein plaques associated with the disease. Specialists believe that this could be the starting point for further studies to develop drugs aimed at curing the disease responsible for most cases of dementia in the world.
The drugs available so far focus on symptomatic treatment, that is, the relief of symptoms. The medical community hopes that the marketing of the new drug will contribute to slowing down the advance of cognitive decline in diagnosed patients, guaranteeing them more autonomy for a longer period of time.
Although the evidence is encouraging, the use of lecanemab divides opinions due to the risk of serious side effects. “The results seem quite encouraging, but we need to be cautious until the data are properly reviewed”, ponders neurologist Denise França, from Hospital Sírio-Libanês.
In 2021, another monoclonal antibody also caused an uproar in medicine. Aduhelm was approved by the FDA even after a committee of independent advisers and a board of senior US agency officials voted against it, saying there was not enough evidence to prove its safety and effectiveness.
The scientific community claims that the accelerated decision, without clarity about the outcome of the patients, was given after pressure from the pharmaceutical industry.
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Alzheimer’s is a degenerative disease caused by the death of brain cells that can appear decades before the first symptoms appear.
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Because it is a disease that tends to get worse over the years, early diagnosis is essential to delay the progression. Therefore, when presenting any symptoms of the disease, it is essential to consult a specialist.
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Although the symptoms are more common in people over 70 years of age, it is not uncommon for them to manifest in young people around 30. In fact, when this “premature” manifestation occurs, the condition is called early Alzheimer’s.
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In the initial phase, a person with Alzheimer’s tends to have changes in memory and starts to forget simple things, such as: where he kept his keys, what he had for breakfast, someone’s name or even the season of the year.
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Disorientation, difficulty remembering the address where you live or the way home, difficulties in making simple decisions, such as planning what you are going to do or eat, for example, are also signs of the disease.
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In addition, loss of desire to perform routine tasks, change in behavior (making the person more nervous or aggressive), and repetitions are some of the most common symptoms.
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According to research carried out by the Alzheimer’s Drugs Discovery Foundation (ADDF), the presence of damaged proteins (Amyloid and Tau), vascular diseases, neuroinflammation, failure of neural and genetic energy (APOE) may be related to the onset of the disease.
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Alzheimer’s treatment is done with the use of medications to reduce the symptoms of the disease, in addition to being necessary to perform physical therapy and cognitive stimulation. The disease has no cure and care must be taken until the end of life
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study with lecanemab
About 1,800 people aged 50 to 90 years with mild cognitive impairment or mild dementia due to Alzheimer’s were followed for 18 months during the lecanemab clinical trial. They were divided into two groups: one received the drug treatment and the second a placebo. Those who tried the medication had a cognitive decline 27% slower than participants in the control group.
“When we look at the data, it is a high number, but it was not clear whether the patient himself had the perception of an improvement in his quality of life and in his routine”, emphasizes Denise.
The neurologist explains that the time of the study is short to state whether the results will be sustained or not. Furthermore, the research did not look at the results in people with the disease in more advanced stages and caused serious side effects in some of the volunteers.
serious side effects
Some of the study participants developed severe brain damage. At least three people died after suffering swelling or bleeding in the brain. However, the manufacturer does not confirm the relationship between the cases and the medication.
The lecanemab label should carry a warning about the risk of developing a type of swelling or bleeding in the brain. He should also recommend monitoring the patient with MRI scans in the initial six months of treatment.
Despite the effects observed, the neurologist Joy Snider, one of the authors of the study, evaluates the results with optimism. “I’m on the side that it’s not perfect, but it’s a step in the right direction,” she said.
Neurologist Alberto Espay, from the University of Cincinnati, has the opposite opinion. He co-authored a paper with 11 other academics who signaled discomfort with the FDA’s approval of lecanemab.
“I think this drug should not be approved because of the lack of safety seen with the side effects,” Espay said in an interview given shortly before FDA approval.
Cure for Alzheimer’s?
The treatments are not intended to cure Alzheimer’s, but to slow down the development of the disease. However, the researchers believe that the new studies pave the way for further research with this approach.
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