A Boston hospital will conduct human trials to test the safety and efficacy of a vaccine to counter Alzheimer’s disease next month. It will mark the first clinical trial of a nasal vaccine for the dementia-causing disorder.
In a statement on Tuesday, the city’s Brigham and Women’s Hospital said the initial phase-one trial will involve 16 patients between the ages of 60 and 85 who exhibit early symptoms of Alzheimer’s but are otherwise healthy. The participants will be given two doses of the vaccine a week apart.
They will receive varying doses over six months, starting in early December, with researchers doing blood testing to determine the appropriate dosage, Dr. Howard Weiner told the Boston Globe newspaper. He called the trial a “remarkable milestone” that follows 20 years of research.
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.
According to the hospital's statement, the vaccine uses Protollin, a substance that activates the body’s immune system by signaling white blood cells in nearby lymph nodes to travel to the brain and clear out the disease’s “hallmark” beta-amyloid plaques.
Although the hospital noted that Protollin has been found to be safe in other vaccines, the researchers will have to observe how it impacts the patients’ immune response and its effects on white blood cells. This will partly “determine the safety and tolerability of the nasal vaccine” in the trial.
Following the six-month period, there will be a trial of 150 patients who will be “treated for years” with the aim of getting a dose every month for the first year, Dr. Weiner told Fox News.
According to several calculations, less than 10% of drugs entering initial trials go on to win regulatory approval. Problems can arise even after the approval process – as was seen earlier this year when independent advisers raised concerns over the side effects of ‘Aduhelm’, an FDA-approved drug for Alzheimer’s.
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