University of Iowa Health Care is evaluating a synthetic version of vitamin B1 for the treatment of Alzheimer’s disease
University of Iowa Health Care is conducting a new, national Alzheimer’s disease (AD) clinical research study evaluating the potential benefits of benfotiamine, a synthetic version of thiamine or vitamin B1, as a treatment for mild cognitive impairment (MCI) or early AD.
The Phase 2 study, called BenfoTeam, will evaluate the effects of benfotiamine on cognitive function and preservation and/or potential improvement in daily routine activities. UI Health Care is one of nearly 50 sites in the U.S. participating in the BenfoTeam study. The study is funded by the National Institutes of Health’s National Institute on Aging.
“In the U.S. there are nearly seven million people living with Alzheimer’s disease and it is the fifth leading cause of death in people over 65. We are urgently in need of new treatment options for people living with this devastating disease,” said Delwyn Miller, MD, professor of psychiatry at the UI Carver College of Medicine. “Currently approved Alzheimer’s disease treatments have, at best, a small impact on cognitive decline and benefit only a subset of patients. Additionally, access to currently approved Alzheimer’s disease medications can be challenging for many people living with the disease. The BenfoTeam clinical trial is studying benfotiamine, a potential treatment that is readily accessible, scientifically compelling, and cost-effective – that’s a trifecta for a potential Alzheimer’s disease therapy in a Phase 2 trial – and it has a strong safety profile.”
Can boosting vitamin B1 slow cognitive decline in Alzheimer’s disease?
Alzheimer’s disease (AD) is the most common type of dementia and develops when nerve cells in the brain no longer function normally. AD causes problems with memory, thinking and behavior. Symptoms usually develop slowly and worsen over time, becoming severe enough to interfere with daily tasks.
Vitamin B1 (thiamine) is crucial for brain function and energy production, and a lack of vitamin B1 is closely linked to thinking, memory, and learning problems. The brain tissue in people with AD shows a marked thiamine deficiency despite sufficient levels of thiamine in a person’s blood. BenfoTeam neuroscientists think that delivery of vitamin B1 (thiamine) via the prodrug benfotiamine will increase the chances of thiamine getting to the brain.
The new clinical trial will determine whether significantly increasing the amount of thiamine in the blood can help thiamine-dependent brain processes and slow down Alzheimer’s-related cognitive decline in people with mild cognitive impairment and early AD.
To enroll, participants must be between ages 50-89 and have mild memory problems or mild dementia due to AD. For more information about participating in the study at UI Health Care, call 319-353-5158 or visit benfoteam.org. Given that Hispanic and Black communities experience a disproportionate burden of the disease, the trial is emphasizing enrollment of participants from underrepresented minority groups.
Previous research from a 12-month, single-site pilot trial in people with early AD demonstrated benfotiamine was safe and well tolerated, with encouraging results in how the body processed and responded to the treatment. For example, the increase in the Alzheimer’s Disease Assessment Scale-Cognitive Subscale was 43% lower in the benfotiamine group than in the placebo group, indicating less cognitive decline. The trial also provided preliminary evidence of the efficacy of benfotiamine on cognitive and functional outcomes that were encouraging data to support the need for this Phase 2 study.
Clinical trial details
The BenfoTeam clinical trial is a randomized double-blind placebo-controlled Phase 2A-Phase 2B trial to evaluate the safety and efficacy of benfotiamine in people with early AD that is taking place at 50 clinical trial sites across the U.S. Participation in the trial will last up to 18 months (plus screening), with a total enrollment of 406 participants. The trial is recruiting people aged 50-89 who have mild memory problems due to AD or who have mild dementia because of AD. The primary objectives of the study are to determine the highest safe and well-tolerated dose of benfotiamine and to assess efficacy of benfotiamine on global function and cognition over 72 weeks.
The BenfoTeam clinical research trial is funded by a grant from the National Institute on Aging (NIA) (R01AG076634). The clinical research trial is coordinated by the Alzheimer’s Disease Cooperative Study (ADCS) at University of California San Diego School of Medicine and is led by principal investigators from the Burke Neurological Institute (Weill Cornell Medicine), Columbia University Irving Medical Center and UC San Diego.
For more information about the trial, visit benfoteam.org.