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A one-of-a-kind clinical trial that will test a nasal vaccine against Alzheimer’s disease is actively recruiting participants at Brigham and Women’s Hospital in what could be a breakthrough treatment.
“If clinical trials in humans show the vaccine to be safe and effective, it could represent a non-toxic treatment for people with Alzheimer’s disease, and it could also be given early to help prevent Alzheimer’s disease. ‘Alzheimer’s in people at risk,’ said Dr. Howard Weiner, co-director of the Ann Romney Center for Neurological Diseases at Brigham, who will lead the research.
The vaccine is administered through the nose and works by stimulating the immune system and activating white blood cells in the lymph nodes. The stimulated cells will travel through the blood and brain to remove toxins and abnormal plaques that are the hallmarks of Alzheimer’s disease.
The trial will mark 20 years of Weiner’s research and the first human trial of a nasal vaccine against Alzheimer’s disease.
Weiner said vaccines are typically given orally, by injection, or intranasally. He and his colleagues found nasal administration to provide the best results. He added that the team saw no major side effects from the vaccine.
The clinical trial will start in a few weeks and will include 16 people receiving different doses to determine the best one.
Participants will be between 60 and 85 years old and will have early and symptomatic Alzheimer’s disease. They will receive two doses of the vaccine one week apart.
Weiner said the process will take about six months and then a second trial with 150 people will begin, which will measure effectiveness and last for about a year.
Weiner told the Herald that the vaccine “can help fight disease and, more importantly, it can be given to people at risk of contracting the disease or who have it and don’t know it.”
He said many people in their 50s and 60s have normal cognition, but brain imaging shows signs of developing Alzheimer’s disease. The vaccine could help these patients.
Patients can find out if they are at high risk of contracting Alzheimer’s disease through the imagination of the brain or through new blood tests that are making their way into the market. Alzheimer’s risk has some genetic components, but they can be sporadic, according to Weiner.
Until now, doctors and researchers knew very little about Alzheimer’s disease and the causes of this tragic disease. But Weiner said recent research into the mechanism of Alzheimer’s disease has led to better understanding, which paves the way for new medical treatments.
“Hopefully after these Phase 1, Phase 2, and Phase 3 trials, we can bring it to market so that doctors can prescribe it in five or six years,” Weiner told the Herald.
Next, Weiner said he hoped the vaccine could be used for disease prevention in large segments of the population.
More than six million Americans live with Alzheimer’s disease and one in three seniors die from the disease or other dementia.
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