Brigham and Women’s Hospital is leading the first human nasal Alzheimer’s vaccine study.
The vaccine is designed to prevent or slow the progression of the disease.
He uses a drug, protollin, to stimulate immune cells to clear sticky plaque from the brain.
A few months ago, treatment for Alzheimer’s disease seemed unlikely.
For 20 years, attempts have been made to develop treatments that will stop the disease from progressing. Several large pharmaceutical companies gave up developing Alzheimer’s therapies altogether. Patients’ only hope of recovery was medication that temporarily relieved symptoms of Alzheimer’s disease – such as memory loss, insomnia, and loss of speech or reasoning -.
But now a breakthrough could be imminent in the field of Alzheimer’s treatment.
Last week Brigham and Women’s Hospital announced that it would lead the first human study with a nasal vaccine for Alzheimer’s disease. The vaccine is designed to prevent or slow the progression of the disease.
Vaccine aims to activate immune cells in Alzheimer’s patients
The study is small: 16 people between the ages of 60 and 85 with Alzheimer’s symptoms receive two doses of the vaccine one week apart. However, it draws on decades of research suggesting that stimulating the immune system can help clear beta-amyloid plaques in the brain. The sticky deposits are a hallmark of Alzheimer’s disease. They form when pieces of beta-amyloid protein accumulate between nerve cells, which can affect people’s ability to think or remember information.
The vaccine sprays a drug called protollin directly into the nasal passage to activate immune cells that are supposed to clear the plaque. The concept isn’t entirely new, but it’s especially promising as scientists now better understand how to treat the disease, Jeffrey Cummings, professor of brain research at the University of Nevada, Las Vegas, told Insider. “The idea of activating immune cells is becoming more and more important for the treatment of Alzheimer’s disease,” says Cummings – and a nasal spray could deliver Protollin to the immune cells better than an infusion or an inhaler.
The results of the study could tell us more about how to stop the disease from getting worse, given that participants are in the early stages of the disease and otherwise must be in good health. Before the nasal vaccine can be incorporated into larger studies, however, researchers need to demonstrate that it is safe. They also have to determine the dose to be administered.
Alzheimer’s research has made significant progress in recent years
The nasal vaccine study is in a very successful year for Alzheimer’s treatment.
In June the US Food and Drug Administration (FDA) approved the first new Alzheimer’s drug in almost 20 years, an antibody infusion called Aduhelm. However, this approval quickly became controversial: Many scientists questioned whether the drug deserved the go-ahead from the FDA because clinical trials clearly showed that it had not improved memory or cognitive abilities.
Aduhelm has been shown to lower the amount of sticky plaque in the brains of Alzheimer’s patients, but an FDA advisory committee found there wasn’t enough evidence of an effective treatment. Part of the skepticism stemmed from the fact that the drug’s maker, Biogen, stopped late-stage clinical trials in 2019 because it believed the drug would fail. Then, about six months later, a small group of participants began to show positive results.
“Biogen stopped the study because they thought it was hopeless, then followed up on patients and it turned out to be not futile – but of course that created a great deal of controversy over the interpretation of the data,” said Cummings. The FDA voted to approve the drug through a special expedited process that gives the green light to drugs that are likely to be of benefit to patients, even if there is still uncertainty about how well they work.
Alzheimer’s is a widespread disease in the USA and Germany
Up to 5.8 million Americans live with Alzheimer’s disease – one of the leading causes of adult death in the United States. According to the latest available data, nearly 122,000 Americans died from the disease in 2019. Around 1.6 million people in Germany live with dementia; most of them with Alzheimer’s. The German Alzheimer’s Society predicts an increase to around 2.88 million people by 2060.
The number of Alzheimer’s deaths in the United States is increasing as more Americans reach old age. From 1999 to 2019, the death rate for Alzheimer’s disease in the United States rose 88 percent – from 16 deaths per 100,000 people to 30 deaths per 100,000 people. This mortality rate may be underestimated because people with cognitive impairments sometimes have difficulty getting an Alzheimer’s diagnosis or other health conditions.
But in the past five years, Cummings says, new technologies like brain scans and blood tests have made it easier to confirm diagnoses of Alzheimer’s and measure how well treatments are working. “It feels like we’ve made a turnaround,” said the brain researcher.
In addition to Aduhelm, several other antibody drugs are also promising. Pharmaceutical company Eli Lilly plans to submit data for its Alzheimer’s drug Donanemab to the FDA by the end of the year, so approval is expected in 2022. Two other companies, Biogen and Eisai, are jointly finalizing an FDA application for their antibody preparation Lecanemab. These other drugs are very similar to Aduhelm, but appear to have “clinical benefits,” Cummings said.
He added, “This is the key: do patients get better, or at least do they lose their cognitive abilities less quickly when treated? That seems to be the case for this whole class of drugs. “
This article was translated from English and edited by Josh Groeneveld. You can do the original here read.