First human trial of Alzheimer’s disease nasal vaccine to begin at Boston hospital

The safety and efficacy test of a nasal vaccination that is designed to prevent and slow down Alzheimer’s disease will take place at Brigham and Women’s Hospital in Boston, Tuesday. After nearly 20 years of research, Howard L. Weiner, MD, codirector of the Ann Romney Center for Neurologic Diseases, at the hospital, the small Phase I clinical trial will be launched.

The 16 participants will be between 60 and 85 years old. They all have early symptomatic Alzheimer’s, but are otherwise healthy. They will receive two doses of the vaccine one week apart, the hospital said in a press release. The Ann Romney Center will enroll the participants. 

A Phase I clinical study is designed to determine the safety and dosage of a potential new drug. If it is successful, a larger trial will be required to confirm its effectiveness.

Protollin stimulates the immune response and is used in the vaccine. “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 clearance of beta amyloid plaques — one of the hallmarks of AD [Alzheimer’s disease]The hospital explained. It mentions that Protollin has been shown to be safe in other vaccines.

Weiner stated in a press release that the hospital had launched the first human trial for a nasal vaccine against Alzheimer’s. “Over the past two decades, we have accumulated preclinical evidence that suggests the potential for this nasal vaccine to AD. If the vaccine proves safe and effective in clinical trials, it could be used to treat Alzheimer’s in people who are at high risk.

The researchers claim they want to “determine safety and tolerability” of the nasal vaccine in the trial. They also intend to observe how Protollin affects immune responses, including white blood cell function.

Weiner stated that “the immune system plays a very significant role in all neurological diseases.” “And it’s exciting to finally take a major step forward in clinical translation after 20 years worth of preclinical work and conduct this historic first human trial.” 

“Research has in this area have paved the way for our pursuit of a whole new avenue to potentially treating not only AD but other neurodegenerative conditions,” said Tanuja Chutnis MD, professor of neurology at Brigham and Women’s Hospital and principal researcher of the trial.

I-Mab Biopharma is responsible for the development, manufacturing, and commercialization of Protollin. Jiangsu Nhwa Pharmaceutical is also responsible.

For years, medical researchers have worked around the world to find new drugs to slow down or treat Alzheimer’s disease, the most common form of dementia that affects approximately 6 million Americans. Many of the promising experimental medications that appeared promising in early trials have not been proven effective, leaving patients and their loved ones with few options.

In June, FDA ApprovedBiogen’s is the first drug to treat Alzheimer’s disease in 20 years. Aduhelm. The controversy erupted after independent advisors warned that the controversial drug was not proven to slow brain-destroying diseases and could cause serious side effects.