UH Cleveland Medical Center Currently Recruiting People with Early Alzheimer’s Disease for a Clinical Trial Evaluating Benfotiamine, a Synthetic Version of Thiamine (Vitamin B1)

CLEVELAND—University Hospitals (UH) Cleveland Medical Center 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. UH Cleveland Medical Center is one of nearly 50 sites in the U.S. participating in the BenfoTeam study.

“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 Mohamed Elkasaby, MD, neurologist at UH Cleveland Medical Center and a BenfoTeam investigator. “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.”

“With the BenfoTeam clinical trial, UH Cleveland Medical Center offers a dynamic intervention study that takes a new approach, with a familiar concept,” continued Dr. Elkasaby. “We know that the brain needs thiamine and that people with Alzheimer’s disease have a thiamine deficiency in the brain. This study will determine if benfotiamine can help resolve that deficiency. The BenfoTeam trial is easy to participate in, without a lot of invasive procedures. It is an approachable clinical trial in which we will find out whether thiamine can alleviate or improve the pace of cognitive decline in people with mild Alzheimer’s disease.”

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, 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.

About Thiamine
Thiamine is crucial for brain function and energy production. A lack of thiamine, or vitamin B1, compromises glucose metabolism and is closely linked to thinking, memory and learning problems. The brain tissue in people with AD show a marked thiamine deficiency despite sufficient levels of thiamine in a person’s blood. BenfoTeam neuroscientists think that delivery of thiamine via prodrug will increase the amount of thiamine getting to the brain.

Benfotiamine is a synthetic, or lab-made, version of vitamin B1 (thiamine), which is a prodrug. Prodrugs are inactive medications that transform into the drug within the body. They are developed to optimize a drug’s performance and to address things like tolerability, inadequate brain penetration, delivery, and absorption. The BenfoTeam 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.

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 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. This research will be supported by the NIH’s National Institute on Aging (R01AG076634). This content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH’s National Institute on Aging.

The ClinicalTrials.gov ID number for this study is: NCT06223360.

For more information about the trial and to find a study site, visit: https://www.benfoteam.org/

About 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. AD affects almost seven million Americans and the number of people with AD is expected to rise to nearly 13 million by 2050. Nearly two-thirds of Americans with AD are women and it is the fifth leading cause of death in the U.S. in people over 65. Additionally, approximately 18 percent of Black Americans and 14 percent of Hispanic Americans age 65 and older have Alzheimer’s compared with 10 percent of White Americans age 65 and older.