A nasal Alzheimer’s vaccine begins to be tested in humans

Currently, some 800,000 people in Spain suffer from Alzheimer’s disease, the most common type of neurodegenerative dementia, according to data from the Spanish Society of Neurology (SEN). The SEN estimates that in our country about 40,000 new cases of this disease are diagnosed each year. Given the high incidence of this dementia, the research on its early detection and treatment it is constant in the last decades.

The latest investigation is going to start in the Hospital Brigham and Women’s (Boston, USA), which is ready to start a clinical trial that will test the safety and efficacy of a new Nasally administered vaccine intended to prevent and delay progression Alzheimer’s. According explains the hospital center, the essay represents the culmination of almost 20 years of research directed by Howard L. Weiner, co-director of the Ann Romney Center for Neurological Diseases in Brigham.

“The launch of the first human trial of a nasal Alzheimer’s vaccine is a remarkable milestone, “says Weiner.” Over the past two decades, we have gathered preclinical evidence which suggests the potential of this nasal vaccine for this disease. If human clinical trials show that the vaccine is safe and effective, this could represent a non-toxic treatment for people with Alzheimer’s, and it could also be given early to help prevent Alzheimer’s disease in people at risk. ”

The vaccine uses the immune modulator Protollin, an investigational intranasal agent that stimulates the immune system. This modulator consists of bacteria derived proteins and it has been used safely in humans as an adjuvant to other vaccines. Protollin is designed to activate white blood cells found in the lymph nodes on the sides and back of the neck to migrate to the brain and trigger the shedding of beta amyloid plaques, one of the hallmarks of Alzheimer’s.

“For 20 years, there has been growing evidence that the immune system plays a key role in the removal of beta amyloid. This vaccine takes advantage of a new branch of the immune system to treat Alzheimer’s“, Explain Tanuja Chitnis, Professor of Neurology at Brigham and lead author of the trial. “Research in this area has paved the way for us to seek a whole new path to potentially treat not only this dementia, but also other neurodegenerative diseases. ”

A small study

For now, the trial will start with a small sample: 16 people between 60 and 85 years with symptoms Alzheimer’s, who will receive two doses of the vaccine a week apart. Participants must be in good general health and no disease is expected to interfere with the study and have had a positive amyloid PET scan.

The main goal phase I trial will be determine the safety and tolerability of the nasal vaccine. The research team will also measure the effect of Protollin nasal on the immune response of the participants, including its effects on white blood cells, by examining cell surface markers, genetic profiles, and functional assays.

“The immune system plays a very important role in all neurological diseases,” says Weiner. “AND It is exciting that, after 20 years of preclinical work, finally we can take a key step towards clinical translation and carry out this first historic human trial, “concludes Center co-director Ann Romney.

“Much remains to be seen if it will work”

Despite the great international media coverage which has had the beginning of this experiment, the spokesperson of the SEN Guillermo Garcia Ribas remember that “It is a phase 1 trial, with which there would be two other phases before a drug reaches humans ”.

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“There is much left so that we can know if it will work. This type of trial does not require as much time to evolve as drug trials, as it is a vaccination mechanism, but we are talking about 10 years if everything was a fable “, adds the neurologist at the Ramón y Cajal University Hospital. In addition, he points out that for this investigation to come to fruition it would take a much larger group.

Also remember that only 10% of investigations to treat Alzheimer’s end up being successful. “The important thing is that there is research in the illness”, He adds.

On the other hand, the specialist highlights as relevant that “The mechanism of action is very novel. Of course, everything that is very new is also more likely to fail. It is too early to say whether this will be the cornerstone and a path to success ”.

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