Alzheimer’s disease, which can severely affect memory and behavior, has no known cure, but the first human trial for a potential nasal vaccine that could prevent or slow its progress is set to start soon.
A total of 16 people ages 60 to 85 will be given doses of the vaccine in the clinical trial at Brigham and Women’s Hospital, Harvard University’s second largest teaching hospital, in Boston, Massachusetts, according to a Nov. 16 news release.
Researchers aim to determine the safety and efficacy of the vaccine, “intended to prevent and slow the progression of Alzheimer’s disease,” during the trial.
“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” Dr. Howard L. Weiner, the co-director of the Ann Romney Center for Neurologic Diseases at the hospital, said in a statement.
This trial is a culmination of nearly 20 years of research led by Weiner, who said his team has gathered evidence that suggests the potential impact the nasal vaccine could have on Alzheimer’s.
“If clinical trials in humans show that the vaccine is safe and effective, this could represent a nontoxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s in people at risk,” Weiner said.
The first part of the trial, phase I, is set to begin the first week in December after the researchers received Food and Drug Administration approval to start human trials, Weiner told McClatchy News over the phone.
How the trial will work
During the first phase of the nasal vaccine trial, each of the 16 participants will have early, symptomatic Alzheimer’s and “must be in good general health with no disease expected to interfere with the study,” according to the release.
They will receive two doses of the nasal vaccine one week apart and will be enrolled from the Ann Romney Center.
The trial will be conducted over the course of roughly six months, with groups of four out of the 16 patients receiving different dosages of the vaccine, Weiner said.
“The phase I trial’s primary objective will be to determine the safety and tolerability of the nasal vaccine,” according to the release.
The vaccine uses Protollin, described as an “immune modulator” that “stimulates the immune system.”
Protollin is protein-based and is designed to activate white blood cells inside lymph nodes within one’s neck, according to the release.
It triggers the white blood cells “to migrate to the brain and trigger clearance of beta amyloid plaques — one of the hallmarks of [Alzheimer’s disease],” the release noted.
Beta amyloids are protein pieces and when they clump together, they cause “abnormal” plaques to form in the brain, the Alzheimer’s Association explains online.
Once the best dose is determined during the first phase, it is expected that a second phase will be conducted, this time looking at 150 participants who will be monitored for about a year, Weiner said.
“Then there would be a phase three which would be a registration trial,” he noted, explaining that it would be conducted with even more patients with the goal of getting FDA approval for the vaccine.
When asked about any possible side effects, Weiner said he doesn’t expect any but there’s always the potential for a rare allergic reaction as with any drug.
He explained that the nasal vaccine was first tested in mice, since they can also develop Alzheimer’s, and that there were no impacts to their hearts, livers or kidneys.
“If everything goes well, and these things can take longer than expected, in five or six years it could be approved and doctors could prescribe it,” Weiner said.
What to know about Alzheimer’s
In 2020, roughly 5.8 million Americans were living with Alzheimer’s, a progressive disease that starts with memory loss and leads to potentially not being able to hold a conversation or continue daily activities, according to the Centers for Disease Control and Prevention.
It typically affects older individuals, with the risks heightening with age, and is less commonly seen in younger people, the CDC said.
Every five years, the number of people living with Alzheimer’s in the U.S. doubles in those older than 65, according to the CDC.
What’s more is that by 2060, this number is expected to triple to 14 million people.
Some warning signs of Alzheimer’s are disruptive memory loss, difficulty handling finances, having trouble completing daily tasks, getting lost in places that were previously familiar and more, the CDC explains.
The disease is the sixth leading cause of death for adult Americans.
This story was originally published November 17, 2021 6:48 PM.