Alzheimer's nasal vaccine to enter human trials for the first time, spurring renewed hope for preventing the disease
A lab worker tests a nasal spray (not related to Alzheimer's disease) at a pharmaceutical and beauty factory in Saint-Chamas, France, on Jan. 21. Nicolas Tucat / AFP / Getty Images
Brigham and Women's Hospital is leading the first human study of a nasal vaccine for Alzheimer's disease.
The vaccine is designed to prevent or slow the progression of the disease.
It uses a drug, Protollin, to stimulate immune cells to remove sticky plaque from the brain.
Alzheimer's treatments seemed like an unlikely prospect just a few months ago.
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Drug trials tried for 20 years to develop treatments that would stop the disease's progression and failed, and several large drug companies abandoned the mission of developing Alzheimer's treatments altogether. Patients' only hopes for improvement were drugs that temporarily relieved symptoms of Alzheimer's - such as memory loss, insomnia, and loss of speech or thinking.
Now the field of Alzheimer's treatment could finally open up.
Last week, Brigham and Women's Hospital announced it would lead the first human study with a nasal vaccine for Alzheimer's to prevent or slow the progression of the disease.
The study is small - 16 people between the ages of 60 and 85 with Alzheimer's symptoms will receive two doses of the vaccine one week apart. But it builds on decades of research suggesting that stimulating the immune system can help clear beta-amyloid plaques in the brain. The sticky plaques are a hallmark of Alzheimer's disease. They form when pieces of beta amyloid protein accumulate between nerve cells, which could affect a person's ability to think or get information.
The vaccine sprays a drug called protollin directly into the nasal passage with the aim of activating immune cells to clear the plaque.
The concept isn't entirely new, but it's especially promising now as scientists understand better 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 treatment of Alzheimer's disease," said Cummings. He added that a nasal spray could deliver Protollin to immune cells better than an infusion or an inhaler.
The study results could tell us more about how to prevent the disease from getting worse, since participants need to be in good health at an early stage of their disease and otherwise. However, before the nasal vaccine can move into larger studies, researchers need to demonstrate that it is safe and determine the dose to be given.
Approval of new Alzheimer's drugs after controversy
The Food and Drug Administration campus in Silver Spring, Maryland on October 14, 2015.AP Photo / Andrew Harnik, file
The nasal vaccine study is taking place during a productive year for Alzheimer's treatments.
In June, the Food and Drug Administration approved the first new Alzheimer's drug in nearly 20 years, an antibody infusion called Aduhelm. But that approval quickly became controversial: Many scientists questioned whether the drug warranted the FDA's green light because it didn't definitely improve memory or cognition in clinical trials.
Aduhelm was shown to lower the amount of sticky plaques in the brains of Alzheimer's patients, but an FDA advisory committee noted that there wasn't enough evidence to confirm it worked as a treatment. Part of the skepticism came from the fact that the drug's maker, Biogen, halted late-stage clinical trials in 2019 because it believed the drug would fail. Then, about six months later, a small group of participants showed positive results.
"Biogen stopped the study because they thought it was pointless and then followed the patients, and it turned out it wasn't pointless - but of course that led to a lot of controversy over how the data should be interpreted," said Cummings.
The FDA has voted to approve the drug under a special expedited route that gives the green light to drugs that patients are likely to benefit from, even if there is uncertainty about their effectiveness.
Scientists say they turned Alzheimer's research around a corner
A doctor reviews a PET brain scan at the Banner Alzheimer's Institute in Phoenix.Matt York / Associated Press
Up to 5.8 million Americans live with Alzheimer's - 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.
Alzheimer's deaths are also becoming more common as more Americans reach old age. From 1999 to 2019, the Alzheimer's death rate in the US rose 88% - from 16 deaths per 100,000 people to 30 deaths per 100,000 people. This mortality rate can be underestimated as people with cognitive decline sometimes have difficulty getting an Alzheimer's diagnosis or have other health conditions.
But in the past five years, Cummings said, 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 just feels like we've come around a corner," said Cummings.
In addition to Aduhelm, he said, several other antibody drugs have shown promise. The pharmaceutical company Eli Lilly plans to submit data for its Alzheimer's drug Donanemab to the FDA by the end of the year, which will initiate approval in 2022. Two other companies, Biogen and Eisai, are jointly filing an FDA filing for their antibody drug Lecanemab.
"These other drugs, which are very similar to Aduhelm, appear to have" clinical benefits, "said Cummings.
He added, "This is key: do patients get better, or at least lose their cognitive abilities less quickly, when treated? That seems to be the case for this entire class of drugs."
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