Brigham and Women’s Hospital is in the early stages of testing a new nasal vaccine to fight Alzheimer’s disease, a neurological disorder that impacts the memory and mental function of more than 6 million Americans.
The Brigham’s Ann Romney Center for Neurologic Diseases will enroll 16 participants age 60 to 85 who have an early, symptomatic version of the disease, the hospital said Tuesday. Each participant will receive two doses of the vaccine one week apart.
Romney center codirector Dr. Howard L. Weiner called the trial “a remarkable feat,” rooted in 20 years of research.
“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 added.
The treatment faces steep odds of success, as only around 10 percent of new drugs entering early trials ultimately win regulatory approval.
Participants will be given varying doses within six months, starting in early December, Weiner said in an interview. Researchers will determine the appropriate dose using blood tests.
The vaccine harnesses the power of the immune system to eliminate beta-amyloid plaques — one of the hallmarks of Alzheimer’s. Experts, however, disagree on whether beta-amyloid plaques are connected to the cognitive decline that Alzheimer’s patients experience.
The experimental vaccine uses Protollin, an immune modulator made of proteins, to activate white blood cells found in lymph nodes on the sides and back of the neck. Those then travel to the brain and trigger clearance of the plaque, according to Tuesday’s announcement.
Prontollin was developed by I-Mab Biopharma and Jiangsu Nhwa Pharmaceutical, which are funding the trial.
The Phase 1 study will determine whether the vaccine is safe and allow researchers to measure the effect of nasal Protollin on participants’ immune response.
It’s a different approach from Aduhelm, the controversial Alzheimer’s drug launched by Cambridge-based Biogen earlier this year. A monoclonal antibody made from the immune cells of older people, the drug has drawn harsh critique from the medical community, who have questioned whether it works.
Mass General Brigham, the health care provider that includes Brigham and Women’s, opted against offering monthly infusions of Aduhelm in September.
The Brigham-tested vaccine could be different, Weiner said, with “a new mechanism of action.”
“Many of the other drugs work by giving an antibody — they infuse it into the bloodstream to go into the brain,” he said. “This [vaccine] is exciting because it uses the body’s own immune system to fight the disease.”