Alzheimer’s treatments seemed unlikely just a few months ago. For 20 years, drug tests have tried and failed to produce treatments that stop the disease from progressing, and several pharmaceutical companies have completely abandoned their mission to develop treatments for Alzheimer’s.
The only hopes for patients to improve were medications that alleviated Alzheimer’s symptoms – such as memory loss, insomnia, and loss of language or reasoning skills – for a limited period of time.
Now, the field of Alzheimer’s treatments may finally open up. Last week, Brigham and Women’s Hospital announced that it would conduct the first human test of a nasal Alzheimer’s vaccine, designed to prevent or slow the progression of the disease.
The study is small – 16 people aged 60 to 85 with Alzheimer’s symptoms will receive two doses of the vaccine a week apart.
But it is based on decades of research suggesting that boosting the immune system may help eliminate beta-amyloid plaques from the brain. These sticky patches are a hallmark of Alzheimer’s disease. They form when pieces of beta-amyloid protein accumulate between nerve cells, which could disrupt a person’s ability to think or remember information.
The vaccine sprays a drug called Protollin directly into the nasal passage, in order to activate the immune cells to remove the plaque.
The concept is not entirely new, but it is particularly promising now that scientists better understand how to treat the disease, Jeffrey Cummings, a professor of brain science at the University of Nevada, Las Vegas, told Insider.
“The idea of activating immune cells is becoming increasingly central to the idea of treating Alzheimer’s disease,” Cummings said. He added that a nasal spray could be better for delivering Protollin to immune cells than an infusion or an inhaler.
The results of the study could tell us more about how to counteract the evolution of the disease, because the participants must be in an early stage of the disease and, otherwise, be in good health. However, before the nasal vaccine can advance to further studies, researchers must demonstrate that it is safe and determine what dose to administer.
The nasal vaccine test comes during a prolific year for Alzheimer’s treatments. In June, the Food and Drug Administration approved the first new drug for Alzheimer’s in nearly 20 years, an infusion of antibodies called “Aduhelm.” But this approval quickly became controversial: Many scientists questioned whether it received FDA approval because it did not permanently improve memory or cognition in clinical trials.
“Aduhelm” has been shown to reduce the level of sticky plaque on the brains of Alzheimer’s patients, but an FDA advisory committee has determined that there is not enough evidence to confirm that it works as a treatment. Part of the skepticism stemmed from the fact that the drug’s manufacturer, Biogen, discontinued advanced clinical trials in 2019 because it assumed the drug would fail. Then, about six months later, a small group of participants began to show positive results.
“Biogen stopped the study believing it was useless, then followed up on patients and it turned out not to be useless – but, of course, this created a lot of controversy in interpreting the data,” Cummings said.
Disease spread to millions of people
Up to 5.8 million Americans live with Alzheimer’s – one of the leading causes of death among adults in the United States. Nearly 122,000 Americans died from the disease in 2019, according to the latest available data.
Deaths from Alzheimer’s are also becoming more common as more and more Americans reach old age. From 1999 to 2019, the US mortality rate for Alzheimer’s increased by 88% – from 16 deaths per 100,000 people to 30 deaths per 100,000 people. This mortality rate can be an understatement, as people with cognitive decline sometimes have difficulty finding a diagnosis of Alzheimer’s or suffering from other health conditions.
But over the past five years, new technologies, such as brain scans and blood tests, have made it easier to confirm Alzheimer’s diagnoses and measure treatment effectiveness.
In addition to Aduhelm, several other antibody medications have been shown to be promising. Pharmaceutical company Eli Lilly plans to submit data for its Alzheimer’s drug, “donanemab,” to the FDA by the end of the year, which puts it on the road to approval in 2022. Two other companies, Biogen and Eisai, are jointly finalizing an FDA application for their antibody drug, “lecanemab”.
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