First human clinical trials for nasal vaccine to prevent Alzheimer’s disease set to begin

A vaccine that could prevent the onset of Alzheimer’s disease is beginning its first human clinical trials.

Brigham and Women’s Hospital in Boston, Massachusetts, announced on Tuesday that it is starting a Phase I trial of a nasal spray that could prevent the devastating condition.

The vaccine will use Protollin, a chemical that stimulates a person’s immune system, and will activate white blood cells that can clear plaques on the brain that cause the Alzheimer’s.

The vaccine is a result of 20 years of research from Dr Howard Weiner, the co-director of the Ann Romney Center for Neurologic Diseases at the hospital.

It would be a breakthrough for the condition that currently has limited available treatments and no drugs that are believed to be able to reverse cognitive decline caused by it.

The clinical trials are being held by Brigham and Women’s Hospital (pictured) in Boston, Massachusetts. The vaccine comes as a result of 20 years of research at the hospital 

‘The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,’ said Weiner in a statement. 

‘Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for [Alzheimer’s disorder]. 

‘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.’ 

The vaccine is a two-dose regimen, that will be administered one week apart.

As of Tuesday, the trial has enrolled 16 participants between the ages of 60 and 85.

All have displayed early symptoms of Alzheimer’s disease, but are in good health otherwise.

The first trial will hope to find whether or not the vaccine is safe, and what dosage doctors should use for it.

Researchers are hopeful that the Protollin in the vaccine can activate white blood cells in a person’s lymph nodes.

In doing so, white blood cells will be triggered to remove beta amyloid plaques from the brain.

It is believed that the plaques, which occur in a person suffering from Alzheimer’s, are the cause for the development of dementia that is associated with the disease.

‘We are thrilled to see Protollin approved to advance into clinical trials after many years of pioneering work, and we are honored to contribute our expertise in the global effort to develop novel therapies for this devastating disease,’ said Dr Jingwu Zang, founder and chairman of I-Mab, a Maryland based biopharma company that developed Protollin, said in a statement.

Weiner is hopeful that this type of triggering of the immune system will be the long sought-after key to fighting the development of Alzheimer’s.

‘The immune system plays a very important role in all neurologic diseases,’ he said. 

‘And it’s exciting that after 20 years of preclinical work, we can finally take a key step forward toward clinical translation and conduct this landmark first human trial.’ 

Alzheimer’s currently affects around six million Americans, and kills more than 100,000 people in the U.S. every year.

Dementia is the most recognized, and most devastating, symptom of the disease – and Alzheimer’s is estimated to be responsible for more than 60 percent of U.S. dementia cases.

It often affects people aged 65 of older, and people with older family members that developed the condition are more at risk of it.

There is only one drug on the market that is believed to be able to reverse the cognitive decline associated with Alzheimer’s, Aduhelm, though many experts doubt the drug’s ability to treat the condition and its approval by regulators over summer was met with controversy.