Brigham and Women’s announces clinical trial for nasally administered treatment of AD
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Brigham and Women’s Hospital will soon commence a clinical trial to test the first nasally administered treatment intended to arrest the progression of Alzheimer’s disease, according to a press release.
The trial arose as a result of nearly 2 decades of research by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at Brigham and Women’s Hospital.
“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” Weiner said in the release. “Over the last 2 decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for AD. 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.”
The vaccine involves Protollin, which, when administered in spray form, stimulates the immune system. According to the release, it is composed of proteins derived from bacteria and has been previously used safely in patients to boost the effectiveness of other vaccines. Protollin is intended to activate white blood cells in the lymph nodes on the sides and back of the neck to migrate to the brain and provoke beta amyloid plaque clearance.
“For 20 years, there has been growing evidence that the immune system plays a key role in eliminating beta amyloid. This vaccine harnesses a novel arm of the immune system to treat AD,” Tanuja Chitnis, MD, professor of neurology at Brigham and Women’s Hospital and principal investigator of the trial, said. “Research in this area has paved the way for us to pursue a whole new avenue for potentially treating not only AD, but also other neurodegenerative diseases.”
The clinical trial will involve 16 participants (aged 60 to 85 years) from the Romney Center who display early symptomatic AD. Participants will be in good general health with no other conditions that could interfere with the study and have an amyloid-positive PET scan. Participants are set to receive two vaccine doses 1 week apart.
The primary goal of the first phase in the trial will be to determine the safety and tolerability of the treatment when administered nasally.
“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.”