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.
The tests, 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 Neurologic Diseases at 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 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.”
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The vaccine operates by using an immune modulator called Protollin, which is an investigational intranasal agent that stimulates the immune system, the hospital said in the release.
“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,” said Dr. Tanuja Chitnis, professor of neurology at Brigham and principal investigator of the trial.
All participants are between 60 and 85 years old with early, symptomatic Alzheimer’s disease, but are in good general health with their disease 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 nasal Protollin on participants’ immune response, including its effects on white blood cells, by examining cell surface markers, gene profiles and functional assays, the release read.
“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.”