What to Know
- The trial will involve 16 participants, all between 60 and 85 years old and with early, symptomatic Alzheimer’s.
- In the first phase of the trial, researchers’ priority is determining whether the vaccine is safe and measuring its effect on participants’ immune systems.
- Alzheimer's disease is the fifth leading cause of death for adults age 65 years and older, according to the Centers for Disease Control and Prevention.
Brigham and Women’s Hospital is launching the first human clinical trial for a nasal vaccine for Alzheimer’s disease.
The vaccine is intended to prevent and slow the progression of the disease. The hospital will begin testing for its safety and efficacy in what is considered a “remarkable milestone," according to lead researcher Dr. Howard Weiner, co-director of the Ann Romney Center for Neurologic Diseases at the Brigham.
“Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for AD,” Weiner said in a statement. “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.”
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The trial will involve 16 participants enrolled from the Ann Romney Center, all between 60 and 85 years old and with early, symptomatic Alzheimer’s. They will receive two doses of the vaccine, one week apart.
In the first phase of the trial, researchers’ priority is determining whether the vaccine is safe and measuring its effect on participants’ immune systems, the hospital said.
“The immune system plays a very important role in all neurologic diseases,” Weiner said. “And it’s exciting that after 20 years of preclinical work, we can finally take a key step forward toward clinical translation and conduct this landmark first human trial.”
More than 6 million Americans are currently living with Alzheimer’s, according to a report by the Alzheimer’s Association. It is the fifth leading cause of death for adults age 65 years and older, according to the Centers for Disease Control and Prevention.
This vaccine uses Protollin, an immune modulator that stimulates the immune system. The agent, which has been safely used in other vaccines, is expected to activate white blood cells in the lymph nodes on the sides and back of the neck to move to the brain and clear it of beta amyloid plaques, one of the hallmarks of the disease.