University of New Mexico researchers are launching a phase 1 clinical trial of a novel Alzheimer’s vaccine designed to clear tau protein from the brain
Researchers at the University of New Mexico have received funding to begin a Phase 1 clinical trial for a groundbreaking Alzheimer’s vaccine designed to clear harmful tau protein from the brain.
Backed by a $1 million grant from the Alzheimer’s Association’s Part the Cloud initiative, the study aims to assess the vaccine’s safety, tolerability, and ability to trigger an immune response. If successful, the trial could mark a significant leap forward in the fight against Alzheimer’s, potentially leading to new and more effective treatment strategies targeting tau, a key driver of Alzheimer’s disease progression.
Targeting the tau protein
In a normal brain, tau protein stabilises the microtubules that form the neurons. Still, when it undergoes a process called phosphorylation, it is ejected from the neurons, creating tangles that are characteristic of Alzheimer’s disease.
In recent years, the FDA has approved drugs that reduce levels of amyloid beta, another target for Alzheimer’s treatment, but they have shown little progress in slowing the disease. This has led many researchers and professionals to begin exploring the tau protein.
Creating an Alzheimer’s vaccine
The scientists have meticulously crafted the vaccine by attaching pT181, a region of the altered tau protein that serves as an Alzheimer’s biomarker, to a virus-like particle (VLP) platform developed by Bryce Chackerian, PhD, and David Peabody, PhD.
VLPs are essentially viruses that have had their genetic material removed, leaving only their outer protein shell. Without a genome, they can’t reproduce, but the body’s immune system still recognises them as invaders and manufactures antibodies to attack them, along with the proteins attached to their surface.
In this case, the pT181 protein segment attached to the surface of the VLP has been shown to trigger an immune response. This immune response leads to the production of antibodies that specifically target the tau protein, leading to the elimination of tau tangles in animal study subjects. This elimination of tau tangles has also resulted in improvements in their cognitive performance, suggesting the potential effectiveness of the vaccine.
The antibodies from the monkeys bound to the human version of the tau protein. The same thing happened when the monkey sera was exposed to tau in brain tissue from people who had died from Alzheimer’s.
However, animal models and test tube experiments are insufficient to prove that the vaccine will work in human subjects. “The bottom line is, yes, we have some immunological data, and it does seem to do well, but we have to move with caution,” Kiran Bhaskar, PhD, professor in the Departments of Molecular Genetics & Microbiology and Neurology, said.
The Alzheimer’s vaccine will be produced in partnership with TheraVac Biologics, a Canadian biotech company that holds an exclusive license to the technology. TheraVac Biologics will be responsible for the production of the vaccine, ensuring it meets the FDA’s “good manufacturing practices” standard, a crucial step in the vaccine’s development and approval process.
The in-human clinical trial will launch in 2026
The new trial will be conducted under the direction of Janice Knoefel, MD, at the UNM Centre for Memory & Aging, which has recently been designated as a federal Alzheimer’s Disease Research Centre.
The trial is expected to start enrolling participants early in 2026 and is anticipated to last for 12 months, according to Bhaskar.
The study will be double-blind, and half of the subjects will receive an active vaccine, while the other half will receive a placebo. Blood tests, antibody tests, cognitive assessments, and other biomarkers will be collected at various points during the trial.
“The primary endpoint of this study is safety and tolerability,” he said. “Can these subjects take these vaccinations without any anticipated side effects or adverse events? The second endpoint is the immunogenicity – can they make antibodies to tau?”
