Optimism to improve the quality of life of millions of people suffering Alzheimer’s disease was born worldwide thanks to the publication of the results of his phase 3 clinical trial Lekanemab, a new drug for degenerative brain disease, in the New England Journal of Medicine. The new drug, developed by Japanese pharmaceutical company Eisai and American Biogen, reduced patients’ cognitive decline by 27% over 18 months, slowing the progression of the disease. Rob Howard, professor of geriatric psychiatry at University College London, said “the results are remarkable and promising,” adding that “this day is historic. We have finally shown that this terrible disease can be controlled and ultimately defeated.”

Lecanemab is a twice-monthly intravenous monoclonal antibody that targets an amyloid protein whose plaques in the brain are a “sign” of the disease. The monoclonal antibody “orders” the immune system to eliminate them.

Clinical researches

Dozens of clinical studies of drugs that limit the concentration of toxic protein have not definitively shown whether “brain cleansing” of protein plaques restores the mental abilities and memory of patients. However, a clinical study of lekanemab has shown for the first time that this approach can actually change the quality of life of patients, maintaining their independence and self-sufficiency for a longer time.

However, many scientists are cautious about the limitations of the new treatment, such as the fact that it is only effective in the early stages of the disease. This means that for a new treatment to be of widespread benefit, a real revolution in the methods of diagnosing the disease will need to be made, perhaps even before the first symptoms appear.

1795 patients participated

The clinical study involved 1795 patients in the early stages of a degenerative brain disease. According to experts familiar with the study, Lecanemab should not be considered a “miracle” as the disease continued to deprive the volunteers of their cognitive abilities despite treatment, but the progression of the disease was slowed down and a rapid deterioration was prevented.

The study data has been submitted to the US Food and Drug Administration, which is expected to decide whether to greenlight its wider use in the coming weeks. Its two manufacturers (Eisai and Biogen) will file similar requests with regulatory authorities in other countries.

Today, the scientific community is concerned about two questions: is the administration of lekanemab safe, and also whether the slowing of cognitive decline provided by its administration, can have practical results in the daily lives of patients and their caregivers.

security issue

Regarding the first question, experts – based on published data – are wary, since serious side effects were recorded during the clinical study.

Moreover, the drug manufacturers acknowledge that some volunteers experienced cerebral edema (13% of volunteers) and hemorrhagic mood (17%), side effects that are often reported with all drugs that act on β-amyloid plaques. It is worth noting that 7% of volunteers were forced to withdraw from the study due to side effects of the drug.

A 65-year-old woman and an 87-year-old man also died during the trial. Both suffered from multiple comorbidities. Eisai’s spokeswoman, referring to the two deaths, stressed that they were not related to lekanemab. The scientists, however, emphasize that more research is needed on the safety of the drug.

The quality of life

Regarding the improvement in the quality of life that the drug can provide, experts make a simple calculation: according to their estimates, it takes about six years after the onset of the first symptoms of the disease for the patient to lose the ability to live independently.

A slowdown in its development by about 25% means about 19 more months of independent life, which is undoubtedly important. They also emphasize that the effect of the drug may be even more beneficial after the 18 months of the clinical trial.

As Professor John Hardy of the British Dementia Research Institute in London notes, Lekanemab “is the end of a war that must be won. This is the first step in which we will create other drugs in the future, until we have really wonderful drugs for Alzheimer’s disease.

Another approach

Scientists who follow the methodology that drug companies are trying to fight Alzheimer’s disease note that so far all drug development efforts have focused solely on amyloid-beta protein plaques, which are just one factor in the highly complex disease. Other factors such as the immune system, inflammation, and another toxic protein, tau, which are located at the exact points where patients’ brain cells die, play a role in the onset of neurodegenerative disease. Professor Tara Spire Jones, head of the Center for Brain Research at the University of Edinburgh, believes that tau is in all likelihood an ideal target for drugs to treat Alzheimer’s disease. However, as he stressed in an interview with the BBC, every small step in the treatment of the disease is “beautiful, because we are gradually gaining a better understanding of the mechanisms of neurodegenerative disease.” The professor also expressed confidence that “over the next decade, something will appear in our pharmaceutical quiver that will truly change the lives and daily lives of patients and their families.”

Numbers

55 millions of people suffer from Alzheimer’s worldwide. It is expected that in 2030 the number of patients will reach 78 million people.

3 seconds is the time between each diagnosis of a person with dementia in the world. In the USA every 65 seconds
a new diagnosis is made.

7th According to the World Health Organization, Alzheimer’s disease is the leading cause of death worldwide. Mortality will skyrocket if there is no significant scientific progress in the fight against it.

65% Alzheimer’s disease deaths are among women, due to several factors, including their longer life expectancy. Overall, women are twice as likely to develop Alzheimer’s disease and live longer than men after diagnosis.

1 trillion The cost for Alzheimer’s patients is estimated worldwide. In 2017, for example, it surpassed Pakistan’s gross domestic product, according to the World Bank.