A week ago, Brigham and Women's Hospital announced it would spearhead the first human trial of a nasal spray vaccine as a protection against Alzheimer's disease, formulated to prevent or delay the progression of the disease.
As specified in a ScienceAlert report, treatments for Alzheimer's disease appeared like impossible prospects before.
Drug trials tested and failed for two decades to produce treatments that would halt the disease's progression, and numerous big pharmaceutical firms abandoned the initiative of developing Alzheimer's treatment altogether.
Therefore, the only hopes of improving patients were drugs that alleviated the symptoms of the disease, which include insomnia, memory loss, and reasoning skills or loss of language, for a limited period.
Human Trial
The human trial involves 16 people aged 60 to 85 years old with Alzheimer's symptoms, who will be given two doses of the vaccine at a one-week interval.
It builds on decades of study suggesting that stimulating the immune system can contribute to the clearing out of beta-amyloid plaques in the brain.
The sticky plaques, as mentioned in Insider, where this new development was originally reported, are a "hallmark of Alzheimer's disease." They form when pieces of beta-amyloid protein build up between nerve cells, possibly disrupting an individual's ability to think or recall information.
The vaccine involves a drug called Protollin which will be directly sprayed into the nasal passage to activate immune cells to eliminate plaque.
A Concept Not Entirely New
According to brain science professor Jeff Cummings from the University of Nevada, Las Vegas, this idea is not totally new, although it is specifically promising now that researchers better understand how the disease is treated.
He explained, the notion of stimulating immune cells is turning more and more "central to the idea of treating Alzheimer's."
Cummings added, a nasal spray could be more effective at delivering Protollin, as detailed in ScienceDirect, to immune cells compared to an inhaler or infusion.
Results of the trial could tell more about how to prevent the progression of the disease since participants need to be at an early stage in the illness and otherwise in good health.
However, before the nasal vaccine can progress to larger trials, scientists need to demonstrate that it is safe to identify what dose to administer.
Approval of the Nasal Vaccine Amidst Some Issues
The nasal vaccine trial comes during a fruitful year for Alzheimer's disease treatments. Earlier this year, in June, the Food and Drug Administration approved the first new drug for Alzheimer's in almost two decades, an antibody infusion known as "Aduhelm."
However, that approval rapidly became controversial. Specifically, many researchers questioned if the drug warranted the green light of the FDA since it did not definitively enhance memory or cognition in a clinical test.
Aduhelm was seen to lower the sticky plaque levels on the Alzheimer's patient's brains. However, an FDA advisory committee claimed that there was no adequate evidence to verify its effectiveness as a treatment.
Part of the doubt stemmed from the fact that Biogen, maker of the drug, stopped late-stage clinical trials in 2019, suspecting the drug would fail. Then, approximately six months after, a small group of participants began to exhibit positive results.
Cummings explained, Biogen for its part, stopped the trial as they thought it was ineffective, then followed the patients, and it appeared not to be useless at all. "But of course," he continued, that created so much controversy in the interpretation of the data.
More Promising Antibody Drugs for Alzheimer's
Other than Aduhelm, Cummings said, a few other antibody drugs have exhibited promise. Pharmaceutical firm Eli Lilly is planning to submit data for its Alzheimer's drug called donanemab, to the FDA by the end of 2021, putting the treatment on track for possible authorization next year.
Two more firms, Eisai and Biogen, work together for the application to the FDA for the lecanemab drug.
These other drugs, said Cummings, which is very like Aduhelm, all appear to be producing clinical benefit - they help patients who are losing their cognitive capability improve their condition. And that appears to be true across the entire class of drugs.
Related report about the nasal vaccine for Alzheimer's is shown on WCVB Channel 5 Boston's YouTube video below:
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