Researchers seek participants for a federally funded study to determine if benfotiamine, a synthetic version of thiamine (vitamin B1), can help slow disease progression
Researchers at Rutgers Robert Wood Johnson Medical School in New Brunswick are enrolling participants in the National Alzheimer's Disease Cooperative Study, which seeks to determine whether benfotiamine, a synthetic form of thiamine (vitamin B1), can help slow cognitive decline in people with mild cognitive impairment and early Alzheimer's disease.
Rutgers is one of about 40 sites in the United States and the only site in New Jersey. This 18-month, Phase 2 clinical trial will evaluate whether benfotiamine, an oral, easily absorbed form of thiamine, can improve cognitive function and help preserve or potentially improvement participants ability to carry out daily routine activities.
"Over 7 million people in the U.S. are living with Alzheimer's disease and an estimated 200,000 Americans ages 30 to 64 have younger-onset dementia, which underscores the need for new treatment options for people living with this progressive disease," said Fred Kobylarz, a professor at Rutgers Robert Wood Johnson Medical School in the Parker Health Group Division of Geriatrics and principle investigator of the study, citing figures from the Alzheimer's Association.
Benfotiamine reduces harmful changes to proteins and other molecules that depend on thiamine, including inflammation, buildup of harmful compounds that stick to proteins and form plaques and tangles that lead to nerve cell damage.
Fred Kobylarz
Professor, Rutgers Robert Wood Johnson Medical School, Parker Health Group Division of Geriatrics
Kobylarz said the brain needs glucose for energy, "but in people with Alzheimer's disease, brain cells often struggle to process that fuel. Benfotiamine works by significantly raising the levels of thiamine in the blood - up to 100 times higher than normal. It also reduces harmful changes to proteins and other molecules that depend on thiamine, including inflammation, buildup of harmful compounds that stick to proteins and form plaques and tangles that lead to nerve cell damage."
By increasing thiamine levels, the treatment aims to help cells process glucose more efficiently, reduce inflammation and stop the buildup of harmful proteins that damage nerve cells.
Researchers are enrolling 10 to 15 participants between 50 and 89 years old who are experiencing mild memory concerns or have been diagnosed with early-stage Alzheimer's disease. Participants can be living at home or in an assisted living facility and should be steady on their current medications for at least three months.
Participants will take benfotiamine or placebo twice daily for 18 months, attend periodic clinic visits for memory tests, blood work and MRI scans and will be monitored for safety and participate with a study partner.
This trial builds upon research from a 12-month, single-site pilot trial in people with early Alzheimer's disease demonstrated benfotiamine was safe and well tolerated, with encouraging results in how the body processed and responded to the treatment. The study, published in the Journal of Alzheimer's Disease in 2020, suggested a slowed rate of cognitive decline in 35 participants with cases of mild cognitive impairment or early Alzheimer's disease who took 300 mg benfotiamine pills twice daily.
