Brigham And Women’s Hospital in Boston is launching a clinical trial to test the safety and efficacy of a nasal vaccine intended to prevent and slow the progression of Alzheimer’s disease (AD).
The trials, which are the first human trial for the intranasal vaccine, represent the culmination of nearly 20 years of research led by Dr. Howard L. Weiner, co-director of the Ann Romney Center for Neurological Diseases in Brigham, the hospital said in a release.
“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” Weiner said. “Over the past two decades, we have accumulated preclinical evidence suggesting the potential of this nasal vaccine for AD. If human clinical trials show that the vaccine is safe and effective, this could represent a non-toxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s disease in people at risk. “
The vaccine works by using an immunomodulator called Protollin, which is an investigational intranasal agent that stimulates the immune system, the hospital said in the statement.
“For 20 years, there has been growing evidence that the immune system plays a key role in the removal of beta amyloid. This vaccine harnesses a new arm of the immune system to treat AD, said Dr. Tanuja Chitnis, a professor of neurology at Brigham and the trial’s principal investigator. “Research in this area has paved the way for us to seek an entirely new avenue to potentially treat not only AD, but other neurodegenerative diseases as well.”
All participants are between the ages of 60 and 85 with early and symptomatic Alzheimer’s disease, but are in good general health and their disease is not expected to interfere with the study. They will receive two doses of the nasal vaccine one week apart.
The primary objective of the phase 1 trial is to determine the safety and tolerability of the nasal vaccine. The research team will also measure the effect of Protollin nasal on participants’ immune responses, including its effects on white blood cells, by examining cell surface markers, genetic profiles and functional assays, the statement read.
“The immune system plays a very important role in all neurological diseases,” Weiner said. “And it is exciting that after 20 years of preclinical work, we can finally take a key step toward clinical translation and conduct this first landmark human trial.”
Translated by Damaris Pérez-Pizarro | The Latino People
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