Researchers are about to begin a clinical trial that will test the safety and efficacy of a new nasally administered vaccine intended to prevent and to slow the progression of Alzheimer's disease.
The Brigham and Women's Hospital in Massachusetts has just announced the launch of a clinical trial for a nasal vaccine against Alzheimer's disease. Remember that the disease directly or indirectly affects nearly 50 million people worldwide . The study represents the culmination of nearly twenty years of research led by Dr. Howard L. Weiner, co-director of the Ann Romney Center for Neurologic Diseases at Brigham.
“The launch of the first human trial of a nasal vaccine against the disease is a remarkable milestone “, he said in a statement. “Over the past two decades, we have amassed preclinical evidence suggesting the potential of this nasal vaccine. If trials show the approach to be safe and effective, it could represent a non-toxic treatment for people with Alzheimer's. It could also be given early to help prevent disease in those at risk “.
While we do not yet have a precise understanding of what causes the disease in the first place, two cerebral phenomena are on the other hand well described. The accumulation in the brain of beta-amyloid peptides on the one hand and the transformation of Tau proteins into abnormally phosphorylated and aggregated forms. Together, these two conditions progressively promote neuronal degeneration in patients.
Previous research has also pointed out that our own defenses can play a key role.
Concretely, this vaccine "will exploit a new arm of the immune system in an attempt to eliminate beta-amyloid plaques in the brain , explains Tanuja Chitnis who co-directs this essay.
The vaccine relies on a drug called Protollin . It is an experimental intranasal agent composed of bacteria-derived proteins. This drug has already been used safely in various vaccines, but as an adjuvant. In other words, it was added to the serum in order to make the other ingredients more effective.
Here researchers will try to assess the effectiveness of Protollin as a real drug. However, as a phase I trial, the real objective will be to measure the safety and the degree of tolerance of the vaccine, to determine the optimal dose and to evaluate the potential side effects.
The trial will involve only sixteen participants between the ages of 60 and 85 , all with early-stage Alzheimer's disease. All will receive two doses of the vaccine administered nasally at weekly intervals.
