A first-of-its-kind clinical trial is underway in the United States, examining the effectiveness of a nasal vaccine for the treatment of Alzheimer’s disease.
The study, to be conducted at Brigham and Women’s Hospital in Boston, began recruiting participants this week, and is the first human trial of a nasal vaccine for the disease.
“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 test an immunotherapy drug called Protollin, which works by stimulating the body’s immune system, targeting a build-up of beta amyloid protein plaques in the brain. Scientists believe these build-ups are one of the ways human brain cells are prevented from working properly in Alzheimer’s.
According to a hospital press release, the phase one trial will involve 16 participants between the ages of 60 and 85 who have early symptomatic Alzheimer’s disease but are otherwise in good health. They will each receive two doses of Protollin, one week apart.
Protollin has been found to be safe in other vaccines, and Weiner told the Boston Herald that his pre-trial research showed that a nasally administered dose provides the best results, and did not reveal any major side effects.
Weiner told the Herald 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 effect of the vaccine on participants’ immune response by measuring white blood cell counts.
Phase one of the trial will last about six months, and then a year-long second trial of 150 people will begin.
Alzheimer’s is a type of dementia that can deteriorate a person’s memory, thinking and behaviour. Eventually these cognitive symptoms become severe enough to interfere with daily tasks. It’s the most common cause of dementia and accounts for 60 to 80 per cent of all dementia cases.
The Alzheimer’s Association estimates that more than 747,000 Canadians are living with Alzheimer’s or another form of dementia.
According to the National Institute on Aging (NIA), scientists haven’t been able to pin down the exact causes of Alzheimer’s, but believe it probably includes a combination of genetic, environmental, and lifestyle factors.