Better than nothing
Alzheimer's drug has shown efficacy in Phase Two trials
Vasily Parfenov, Naked Science
Above is the brain of a healthy person, below is the brain of a person affected by Alzheimer's disease in comparable periods of life. / ©Applied Radiology.
In a press release, Lilly's Donanemab Slows Clinical Decline of Alzheimer's Disease in Positive Phase 2 Trial, pharmaceutical company Eli Lilly announced optimistic news. The drug donanemab developed by its specialists contains monoclonal antibodies to beta-amyloids. The principle of its action is based on the prevention of the formation of so–called amyloid plaques. According to one theory, by attacking these formations in the brain, it is possible to achieve stabilization of the patient's condition or even cure. However, prior to donanemab trials, no drug targeting peptide plaques had demonstrated sufficient efficacy.
272 patients participated in the tests of the new phase II drug, whose brain scans showed mild to moderate Alzheimer's disease. As noted by Daniel Skovronsky, chief researcher at Eli Lilly, it was important to choose those who had amyloid plaques that had already begun to form in a noticeable amount, but there were still not too many of them. They were given injections of donanemab or placebo every four weeks. At the same time, the patients were evaluated by specialists on a number of parameters. The patients underwent a series of tests for cognitive abilities and memory, and it was also taken into account how well they were able to cope with household chores.
Preliminary results of experimental treatment are encouraging: the drug was able to slow down the development of dementia by 32 percent. In addition, the peptide plaques in the patients' brains disappeared and stopped forming within 6-12 months. After the symptoms disappeared, the subjects received only a placebo – this was how the durability of the donanemab effect was tested. Of the possible side effects, only an increased amount of fluid in the brain was recorded, but this did not affect the condition of the volunteers. In the near future, Eli Lilly employees will continue to analyze the data received. Skowronski promised that as soon as everything is ready, the company will release a detailed report, and the results will be published in a peer-reviewed journal.
While detailed data is not disclosed – the study has not yet been completed. Even the proportion of patients whose condition has improved is unknown. Nevertheless, the news is positive: there are incredibly few drugs for Alzheimer's disease, and promising drugs fail tests one after another.
But it's too early to rejoice. Donanemab will have another phase II trial, which will begin in the near future and will last at least until 2023. After that, it will be necessary to conduct a large-scale study of the third phase on a larger sample of patients. And only then will the widespread use of the new drug become possible. Although in some cases, the US Food and Drug Administration (FDA) may allow the use of donanemab earlier.
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