A new kind of clinical trial is under way in the United States. It will examine the effectiveness of a nasal vaccine treatment for Alzheimer’s disease.
This first human trial of a nasal vaccine for the disease will be conducted at Brigham and Women’s Hospital in Boston. Providers will start recruiting participants this week.
“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,” Dr. Howard Weiner, co-director of the Ann Romney Center for Neurologic Diseases at the Brigham, who will lead the research, said in a statement.
The vaccine will be used in testing Protollin, a new type of immunotherapy
that stimulates the body’s immune system to fight against a build-up of beta amyloid protein plaques in the brain.
Scientists believe these build-ups are one of the ways human brain cells have difficulty working properly with Alzheimer’s.
Phase one of the trial involves 16 participants between the ages of 60 and 85 who have early symptomatic Alzheimer’s disease but are otherwise in good health. Each will receive two doses of Protollin, one week apart.
Protollin has been found to be safe in other vaccines, and Weiner said that his pre-trial research showed that a nasally administered dose provides the best results, and did not reveal any major side effects.
Weiner said that the vaccine “can help with the disease and even more importantly, it can be given to people who are at risk for the disease or have it and don’t know it.” He said, “many people in their 50s and 60s show signs of developing Alzheimer’s in brain imaging, despite having normal cognition.”
The trial will be used to determine “the safety and tolerability of the vaccine,” according to the hospital’s statement. Researchers will also track the effectiveness of the vaccine on participants’ immune responses by measuring white blood cell counts.
The first phase of the trial will last about six months, and then a year-long second trial of 150 people will begin.