A groundbreaking clinical trial of a nasal vaccine for Alzheimer’s disease that has been decades in the making is set to begin at Brigham and Women’s Hospital in Boston, according to hospital officials.
The goal of the trial is to test the safety and efficacy of the vaccine that is delivered nasally and intended to prevent and slow the progression of Alzheimer’s disease (AD).
Dr. Howard L. Weiner, co-director of the Ann Romney Center for Neurological Diseases at Brigham described the launch of the first human trial of a nasal vaccine for Alzheimer’s disease, “a remarkable milestone.”
The clinical trial will include 16 participants between the ages of 60 and 85, who all show early symptomatic Alzheimer’s, but are otherwise generally healthy, the hospital said in aPress release
Each person will be given two doses of vaccine, one each week. According to the release, participants will register at the Ann Romney Center.
Researchers believe the vaccine contains Protollin, a substance that stimulates the immune system. It has also been shown to be safe in other vaccines.
“Protollin 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,” according to the release.
Researchers said phase I trial’s primary objective will be to “To determine safety and tolerability,” and observe how Protollin affects participants’ immune response, including how it affects their white blood cells.
Weiner said the nasal vaccine is a “unique approach” by affecting a person’s immune system. He spoke enthusiastically with CBS News about the vaccine trial launch.
“Potentially it could be a treatment for people with the disease, and even more important it could be something to prevent people from ever getting the disease,” Weiner said.
Tanuja Chitnis, MD, professor of neurology at Brigham and Women’s Hospital and principal investigator of the trial, said: “Evidence has grown over the past 20 years to show that beta-amyloid is eliminated by the immune system. This vaccine harnesses a novel arm of the immune system to treat AD,” she said.
Chitnis also added: “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.”
Jiangsu Nhwa Pharmaceutical and I-Mab Biopharma are responsible for the development, manufacture, and marketing of Protollin.