Nasal Vaccine For Alzheimer's Disease Set To Begin Phase I Trial

Alzheimer's Disease is the fifth leading cause of death in the over 65s. Image: Image Point Fr/Shutterstock

As Benjamin Franklin once famously quoted, only two things in this world are certain: death and taxes. Well, we might not be able to do much about the taxes part (not without a Twitter poll, at any rate), but humans have gotten pretty good at staving off death over the past century or so. But with extended lifespans come other issues, like dementia – the cognitive degenerative syndrome currently affecting around 9 million Americans.

Accounting for between six and eight in every ten cases, Alzheimer’s is by far the most common type of dementia. This week, the Brigham and Women’s Hospital in Massachusetts made an exciting announcement: the launch of a clinical trial for a nasal vaccine against this devastating syndrome.

“The launch of the first human trial of a nasal vaccine for Alzheimer’s is a remarkable milestone,” said Howard Weiner, MD, whose nearly 20 years of research formed the background of this week’s announcement. “Over the last two decades, we’ve amassed preclinical evidence suggesting the potential of this nasal vaccine for [Alzheimer’s disease].”

As the US population ages up over the next couple of decades, the number living with the condition is projected to more than double  – it’s already the sixth most common cause of death in the US, with no known cure and very few treatment options. So a working vaccine would be a massive boon, even for those currently suffering from the condition, since Weiner hopes the spray could function as both a treatment and a prophylactic measure.

“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,” he said.

It might seem unexpected that we could vaccinate against Alzheimer’s disease – after all, while we do basically know how the disease works, we still don’t have a good understanding of what causes it. But over the past few decades, researchers have figured out that the immune system likely plays a key role, leading to the development of a handful of potential vaccines that target this system directly.

“This vaccine harnesses a novel arm of the immune system to treat [Alzheimer’s]” said Tanuja Chitnis, MD, neurology professor and principal investigator of the trial. “Research in this area has paved the way for us to pursue a whole new avenue for potentially treating not only [Alzheimer’s], but also other neurodegenerative diseases.”

The trial will involve 16 participants between the ages of 60 and 85, all of whom have early-stage Alzheimer’s disease but no other major health issues. They are set to receive two doses of the vaccine, delivered nasally one week apart.

The vaccine itself uses a drug called Protollin, an “immune modulator” that can trigger white blood cells to clear beta amyloid plaques in the brain – one of the hallmarks of Alzheimer’s disease. It’s been safely used in vaccines for the best part of two decades, but as an adjuvant to make the other ingredients more effective – part of the Brigham trial will be spent assessing Protollin’s effectiveness as a drug in its own right. As a phase I trial, however, the main objective is to measure the vaccine’s safety and tolerability – figuring out the optimum dose, potential side effects, and so on.

“The immune system plays a very important role in all neurologic diseases,” said Weiner. “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.”

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