The first Alzheimer’s nasal vaccine trial in humans begins at Boston Hospital

Brigham and Women’s Hospital is testing the safety and effectiveness of a nasal vaccine aimed at preventing and slowing down Alzheimer’s disease, Boston Hospital announced Tuesday. The start of a small, phase I clinical trial comes after nearly 20 years of research led by Howard L. Weiner, MD, director of the Ann Romney Center for Neurological Diseases.

The experiment will involve 16 participants aged 60 to 85, all of whom have early symptomatic Alzheimer’s disease but who are otherwise generally healthy. They receive two doses of the vaccine every week, the hospital said in a press release. Participants register at the Ann Romney Center.

A Phase I clinical trial is designed to determine the safety and dosing of a potential new drug. If it goes well, a much larger experiment is needed to test its effectiveness.

The vaccine uses a substance called Protollin, which stimulates the immune system. “Protollin is designed to activate the white blood cells in the sides and back of the lymph nodes in the neck to travel to the brain and trigger the clearance of beta-amyloid plaques – one of the hallmarks of AD. [Alzheimer’s disease]The hospital explains. It states that Protollin has been shown to be safe in other vaccines.

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View from Brigham and Women’s Hospital in Boston, Massachusetts, March 7, 2020.

Through Joseph Prezioso / AFP Getty Images


“The launch of the first human trial of the Alzheimer’s nasal vaccine is a significant milestone,” Weiner said in a hospital press release. “Over the past two decades, we have gathered preclinical evidence suggesting the possibility of this nasal vaccine in the treatment of AD. If human clinical trials show that the vaccine is safe and effective, this may be a non-toxic treatment for people with Alzheimer’s disease. to prevent the disease in at-risk groups. “

The researchers say they are working to “determine the safety and tolerability of the nasal vaccine” in the study and to monitor how Protollin affects participants’ immune responses, 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 an important step forward in clinical translation and complete this significant first human experiment.”

“Research in this area has paved the way for a whole new path in the treatment of potentially AD, but also other neurodegenerative diseases,” said Tanuja Chitnis, MD, professor of neurology at Brigham and Women’s Hospital and principal investigator of the study. trial.

I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical are responsible for the development, manufacture and commercialization of Protollin.

Medical researchers around the world have been working for years to develop new drugs to treat or slow down Alzheimer’s disease, the most common cause of dementia, and dementia affects an estimated 6 million Americans. But many of the experimental drugs that once seemed promising in early studies have not disappeared, so there are few good treatment options for patients and their families.

In June, the FDA admitted The first new drug for Alzheimer’s disease in 20 years, Biogen Aduhelm. However, the decision was controversial after warnings from independent advisers that the much-disputed drug has not been shown to help slow down a brain-destroying disease and carries a risk of serious side effects.

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