The Brigham and Women’s Hospital in Massachusetts are reportedly beginning Phase 1 trials of a nasal vaccine for Alzheimer’s disease.
Interest and research in nasal vaccines have considerably increased over the years. Scientists have explored an intranasal mode of administration for multiple diseases, including COVID-19 and flu. Recently, a team at Brigham and Women’s Hospital launched a clinical trial of a nasal vaccine for Alzheimer’s disease. According to the press release, the phase 1 trial will assess the vaccine’s safety and tolerability among 16 participants with early, symptomatic Alzheimer’s disease. As part of the trial, the participants will receive two doses of the nasal vaccine, one week apart.
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.
Dr. Howard Weiner, lead researcher
Alzheimer’s disease is the most common cause of dementia, accounting for 60-80% of cases. The progressive disease commonly affects adults aged 65 years and above. Furthermore, it typically presents with memory loss, cognitive decline, and behavioural changes. A build-up of beta-amyloid plaques and neurofibrillary tangles are considered a hallmark of the disease. There is currently no cure for the disease; however, the drug Aduhelm has received FDA approval for the treatment of Alzheimer’s. Although its approval has faced some backlash from critics, FDA has so far stuck by its decision.
Researchers are now working on an effective vaccine that can prevent the development of the disease. An effective vaccine will not only help prevent further progression of the disease but also any new cases.
‘A Remarkable Milestone’
Dr. Howard Weiner, who led the research, has spent over 20 years working on the vaccine. He described the launch of the phase 1 trial as a ‘remarkable milestone’ in the step towards an effective Alzheimer’s vaccine. The study author further stated the importance of the vaccine in helping those most at risk.
The vaccine uses an immune modulator called Protollin to stimulate an immune response. Protollin works by activating white blood cells within the lymph nodes in the neck. These then migrate to the brain and cause the clearance of beta-amyloid plaques. Previously, researchers have used Protollin in other vaccines. However, all previous formulations used Protollin as an adjuvant. This is the first time the immune modulator will be assessed as an independent drug.
The immune system plays a very important role in all neurologic diseases. 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.
Dr. Howard Weiner, lead researcher
Along with determining the vaccine’s safety and tolerability, the trial will also focus on finding the vaccine’s optimum dose and its effect on the participants’ immune response.
Source: Brigham and Women’s Hospital
