24 October 2019

The Return of adukanumab

The next trials of a new drug for Alzheimer's disease were successful

"Scientific Russia"

The amyloid hypothesis of the development of Alzheimer's disease, the main role in which is assigned to the formation of plaques from the beta-amyloid protein, is considered one of the main ones. Clinical trials of the drug Aducanumab (Aducanumab) based on monoclonal antibodies to this pathological protein had to prove or disprove it. But the developer company has once again changed the conclusions based on the results of these tests

Alzheimer's disease is a common cause of dementia, responsible for about 60-70% of cases of senile dementia. There is a lot of debate about its causes and mechanisms. The most popular is the amyloid hypothesis, according to which neurodegenerative processes are largely caused by the accumulation of plaques in the brain consisting of toxic fibrils of beta-amyloid protein. Normally, the molecules of this protein have a spherical shape, but for unknown reasons they can unfold and stick together into filamentous structures.

The antibodies on the basis of which the drug aducanumab was created should recognize amyloid plaques and bind to them, after which the plaques are destroyed by cells of the immune system. In 2016, the developers of the drug announced the first successes of clinical trials of this drug. Against the background of taking aducanumab, there was a decrease in the size of amyloid plaques in the brain tissues of patients and the rate of decline in their cognitive abilities slowed down. These conclusions were made based on observations of a small sample of 165 patients who took the drug for a year. 

But a year later, hopes for a drug for Alzheimer's disease collapsed: tests conducted on a large sample of more than one and a half thousand patients showed that adukanumab is unable to contain the growing cognitive impairment in patients. Therefore, representatives of pharmaceutical companies announced the termination of the third phase of clinical trials of aducanumab. 

But the analysis of the data already obtained, supplemented with information about other patients who did not stop taking the drug, continued. In the end, the full sample was 3,285 people. The new results showed that aducanumab is effective, and so much so that the company Biogen plans to request permission from the U.S. Food and Drug Administration to sell it in early 2020.

If the results of this study are not reviewed again, they will not only give hope to a huge number of patients and their loved ones, but also confirm the amyloid hypothesis of the pathogenesis of Alzheimer's disease. And although such throwing contributes to the skeptical attitude of society towards the reliability of the results obtained, in any case, according to scientists, efforts aimed at finding out the role of beta-amyloid in the development of this disease should be doubled.

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