USA – Clinical trial for Alzheimer’s disease (AD) nasal vaccine has been launched to see whether a potential treatment could be safe for humans after the therapy showed positive results in mouse models that mimic some of the symptoms of the disease.
If the new trial demonstrates that the vaccine is safe in humans, further research will be conducted to determine whether it is also effective.
Brigham and Women’s Hospital announced the trials last week, and they only involve a small number of volunteers — 16 people aged 60 to 85 who have pre-existing Alzheimer’s symptoms. The vaccine will be administered in two doses, one week apart.
Howard L. Weiner, co-director of Brigham’s neurological disease research center, developed the vaccine after studying Alzheimer’s disease for over two decades.
The vaccine is based on decades of research that suggests stimulating the immune system can clear out beta-amyloid plaques, which are the cause of Alzheimer’s disease.
They typically form when beta-amyloid fragments accumulate between nerve cells, impairing a person’s ability to think or remember things.
The vaccine spray, known as Protollin, acts as an immune modulator and is administered through the nasal passage to activate immune cells, specifically white blood cells from the lymph node in the neck area, in order to eliminate the aforementioned plaque.
Alzheimer’s disease affects approximately 60-70 percent of people with dementia worldwide, including nearly 6 million people in the United States.
In certain age groups, it may be the third leading cause of death after cancer and heart disease.
With the world’s population aging, the WHO predicts that the number of people suffering from dementia will rise to 78 million by 2030 and 139 million by 2050.
Memory problems, loss of cognitive function and coordination, and personality changes are the most common symptoms of dementia. The most significant risk factor for dementia is aging — more than 90% of people with dementia are over the age of 65 — but other factors are also at play.
There is currently no cure for dementia, and most treatments only alleviate symptoms rather than slowing the disease’s progression.
The nasal-vaccine trial takes place during a busy year for Alzheimer’s treatments. The Food and Drug Administration approved Aduhelm, an antibody infusion, as the first new Alzheimer’s drug in nearly 20 years in June.
However, that approval was quickly questioned by many scientists, who probed whether the drug deserved the FDA’s approval because clinical trials showed no definitive improvement in memory or cognition.
Aduhelm was shown to reduce the levels of sticky plaque in Alzheimer’s patients’ brains, but an FDA advisory committee determined there wasn’t enough evidence to confirm it worked as a treatment.
Part of the skepticism stemmed from the fact that Biogen, the drug’s manufacturer, halted late-stage clinical trials in 2019, assuming the drug would fail. After about six months, a small group of participants began to show positive results.