BOSTON — Researchers at Boston’s Brigham and Women’s Hospital are launching a clinical trial of a nasal vaccine for Alzheimer’s Disease that’s 20 years in the making.
The trial will test the safety and efficacy of a new vaccine delivered nasally, which is intended to prevent and slow the progression of Alzheimer’s disease.
In a statement, Brigham and Women’s said the trial represents the culmination of nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at the Brigham.
“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” said Weiner. “Over the last two 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.”
Researchers say the vaccine uses the immune modulator “Protollin,” which is an investigational intranasal agent that stimulates the immune system.
Protollin is composed of proteins derived from bacteria and has been used safely in humans as an adjuvant, or ingredient, for other vaccines, according to researchers. It 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 clearance of beta amyloid plaques — one of the hallmarks of Alzheimer’s Disease.
The objective of the phase I trial will be to determine the safety and tolerability of the nasal vaccine.
Brigham and Women’s Hospital says the research team will also measure the effect of nasal Protollin on participants’ immune response, including its effects on white blood cells, by examining cell surface markers, gene profiles, and functional assays.
“The immune system plays a very important role in all neurologic diseases,” said Weiner. “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.”
This is a developing story. Check back for updates as more information becomes available.
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