Benfotiamine is a relative of thiamine, which is better known as vitamin B1. Thiamine is critical for the metabolism of our brain's major energy source—glucose. Benfotiamine, which converts to thiamine in the body, enters cells more easily than thiamine. Although a pilot study of benfotiamine has found cognitive improvement in Alzheimer's disease patients, no clinical studies have determined whether it can prevent age-related cognitive decline or dementia in healthy adults. Benfotiamine appears to be safe when used at standard doses.
No clinical studies have tested whether benfotiamine can prevent age-related cognitive decline or dementia, though one trial is underway now. Our search identified:
• 1 open-label uncontrolled study in Alzheimer's patients
• 3 preclinical studies
Benfotiamine is converted to thiamine, which serves as a key factor for three enzymes involved in generating energy from glucose . Preclinical studies have found that benfotiamine enhances cognitive function and reduces biological markers of Alzheimer's disease . These benefits may be due to benfotiamine's ability to suppress the activity of an enzyme that promotes the progression of Alzheimer's . However, benfotiamine's effects on this enzyme have not been confirmed in humans.
At this time, there are no randomized clinical trial data showing that benfotiamine is beneficial for prevention or treatment of age-related cognitive decline or dementia. A phase II clinical trial now underway, however, is testing whether benfotiamine can slow cognitive decline in patients with mild cognitive impairment or Alzheimer's disease . Results have not yet been published.
There is only one small open-label, uncontrolled study which showed that benfotiamine treatment for 18 months resulted in improved cognitive function in Alzheimer's patients , though the treatment did not decrease levels of beta-amyloid, a protein common in people with Alzheimer's disease. An ongoing phase II placebo-controlled study, supported in part by the Alzheimer's Drug Discovery Foundation, is testing whether benfotiamine slows cognitive decline in patients with amnestic mild cognitive impairment and Alzheimer's disease .
Benfotiamine is generally considered safe for most people when taken at standard doses, though long-term safety has not been studied. In clinical trials, side effects were mild and included gastrointestinal issues and skin reactions . Because benfotiamine gets converted to thiamine (vitamin B1), and thiamine may cause low blood pressure or low blood glucose, people taking drugs or herbs to lower blood pressure or blood glucose should exercise caution .
NOTE: This is not a comprehensive safety evaluation or complete list of potentially harmful drug interactions. It is important to discuss safety issues with your physician before taking any new supplement or medication.
Benfotiamine supplements are available over-the-counter, often in capsules containing 150–300 mg. In an open-label uncontrolled trial, a daily dose of 300 mg showed cognitive improvement in Alzheimer’s disease patients . Other studies in clinical populations have used doses ranging from 200–600 mg/day .
Information on safety and drug interactions with thiamine from the Mayo Clinic
Evaluation of benfotiamine's potential biological effects from Examine.com
The ADDF is sponsoring a phase II clinical trial led by Dr. Gary Gibson at the Winifred Masterson Burke Medical Research Institute. This trial is testing whether benfotiamine slows cognitive decline in patients with amnestic mild cognitive impairment and Alzheimer's disease. Details of this trial can be found by searching "benfotiamine" in the ADDF's Online Portfolio and at clinicaltrials.gov.