Brigham and Women’s Hospital will test the safety and effectiveness of a nasal vaccine aimed at preventing and slowing Alzheimer’s disease, the Boston hospital announced Tuesday. The start of the small, Phase I clinical trial comes after nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurological Diseases at the hospital.
The test will include 16 participants between the ages of 60 and 85, all with early symptomatic Alzheimer’s but otherwise generally healthy. They will receive two doses of the vaccine one week apart, the hospital said in a press release. Participants will register from the Ann Romney Center.
A Phase I clinical trial is designed to establish the safety and dosage for a possible new drug. If it goes well, a much larger test would be needed to test its effectiveness.
The vaccine uses a substance called Protollin, which stimulates the immune system. “Protollin is designed to activate white blood cells found in the lymph nodes on the sides and back of the neck to migrate to the brain and trigger removal of beta-amyloid plaques – one of the characteristics of AD. [Alzheimer’s disease], “the hospital explains. It notes that Protollin has been found to be safe in other vaccines.
“The launch of the first human trial of a nasal vaccine against Alzheimer’s is a remarkable milestone,” Weiner said in the hospital’s press release. “Over the past two decades, we have accumulated preclinical evidence suggesting the potential of this nasal vaccine for AD. If clinical trials in humans show that the vaccine is safe and effective, it could represent a non-toxic treatment for people with Alzheimer’s, and it. could also be given early to help prevent Alzheimer’s in people at risk. “
The researchers say they aim to “determine the safety and tolerability of the nasal vaccine” in the trial and observe how Protollin affects participants ’immune response, including how it affects their white blood cells.
“The immune system plays a very important role in all neurological diseases,” Weiner added. “And it’s exciting that after 20 years of preclinical work, we can finally take a key step forward toward clinical translation and make this landmark a first human test.”
“Research in this area has paved the way for us to look for a whole new way to possibly treat not only AD but also other neurodegenerative diseases,” said Tanuja Chitnis, MD, a professor of neurology at Brigham and Women’s Hospital and lead researcher of the trial. .
I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical are responsible for the development, manufacture and marketing of Protollin.
Medical researchers around the world have been working for years to develop new drugs to treat or slow down Alzheimer’s, the most common cause of dementia that affects about 6 million Americans. But many of the experimental drugs that once seemed promising in early studies did not come out, leaving patients and their families with few good treatment options.
In June, the FDAthe first new drug for Alzheimer’s in 20 years, that of Biogen . However, the decision sparked controversy after warnings from independent counselors that the much-discussed drug has not been shown to help slow the brain-destroying disease and carries the risk of serious side effects.