Alzheimer's treatments were not considered likely just months ago.
Drug trials failed for 20 years to produce treatments that would stop the progression of the disease, and several large pharmaceutical companies abandoned the mission of developing Alzheimer's treatments altogether. The only hope for patients was to take drugs that would help with Alzheimer's symptoms for a limited time.
The field of Alzheimer's treatments may be opening up.
The first human trial of a vaccine for Alzheimer's will be conducted by the hospital.
16 people with Alzheimer's will receive two vaccine doses one week apart in a small trial. It builds on decades of research showing that stimulating the immune system can help clear out plaques in the brain. Alzheimer's disease is caused by sticky plaques. They form when pieces of theamyloid are deposited between nerve cells.
The vaccine sprays a drug called Protollin directly into the nose, with the goal of getting the immune cells to kill the plaque.
The concept isn't completely new, but it's promising that scientists can better understand how to treat the disease, according to a brain science professor at the University of Nevada, Las Vegas.
The idea of treating Alzheimer's disease with activated immune cells is becoming more and more central to it. Protollin could be delivered better with a spray than an injection.
The trial results could tell us more about how to stop the progression of the disease since participants must be in good health. Researchers must demonstrate that the vaccine is safe before it can be used in larger trials.
The drugs were approved in the wake of controversy.
The Food & Drug Administration campus is in Silver Spring, Md.
AP Photo/Andrew Harnik
The trial for a vaccine against Alzheimer's takes place during a busy time.
The first new Alzheimer's drug in 20 years was approved by the FDA in June. The FDA's approval of the drug was controversial because it didn't improve memory or cognitive function in clinical trials.
There wasn't enough evidence to show that Aduhelm worked as a treatment for Alzheimer's patients, despite the fact that it was shown to lower levels of sticky plaque. The drug's maker stopped late-stage clinical trials because they assumed the drug would fail. A small group of participants started to show positive results six months later.
"Biogen stopped the trial thinking that it was futile, then followed the patients and it turned out not to be futile, but of course that created a lot of controversy in the interpretation of the data," he said.
The FDA voted to approve the drug under a special pathway that allows them to greenlight drugs that are likely to benefit patients even when there is uncertainty about how well they work.
Scientists say they have turned a corner on Alzheimer's research.
Dr. William Burke is at Banner Alzheimer's Institute in Phoenix, Arizona.
Matt York is an Associated Press photographer.
Alzheimer's is the leading cause of death among US adults. The latest available data shows that nearly 122,000 Americans died of the disease in 2019.
Alzheimer's deaths are becoming more frequent as Americans get older. The US mortality rate from Alzheimer's rose from 16 deaths per 100,000 people in 1999 to 30 deaths per 100,000 people in 2019. The death rate may be underestimated since people with cognitive decline sometimes have difficulty getting an Alzheimer's diagnosis.
New technologies such as brain scans and blood tests have made it easier to confirm Alzheimer's diagnoses and measure how well treatments are working.
"It feels like we have turned a corner," he said.
He said that Aduhelm and a few other drugs have promise. Eli Lilly plans to submit data for donanemab to the FDA by the end of the year, which will put it on track for possible approval in 2022. Two more companies are working together to get an FDA application for their drug.
"These other drugs that are very similar to Aduhelm seem to be producing clinical benefit," he said. The key is whether patients are better or worse if they are treated. That seems to be the case across this class of drugs.
