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The purpose of this study is to learn more about the safety, effectiveness and tolerability of the study drug called Benfotiamine, to determine whether it delays or slows the progression of the symptoms of early Alzheimer’s disease. The BenfoTeam clinical trial will test if boosting the amount of thiamine that gets to the brain can slow cognitive decline in people with MCI and mild AD by improving thiamine’s actions in the brain.
Benfotiamine is a lab-made version of Vitamin B1 (thiamine). Thiamine is essential to brain health. The brain needs thiamine to use glucose for energy. Dysfunction in the brain’s ability to process glucose is a known marker of AD. Benfotiamine absorbs better than thiamine and BenfoTeam scientists think the drug may raise thiamine levels in the brain. Some participants in this study will take placebo, which are capsules that look like the study drug but do not contain any active drug in them.
Potential participants go through a screening process to determine eligibility for the BenfoTeam clinical trial. Screening and participation includes memory and thinking assessments; a physical examination; brain imaging using MRI, and blood tests.
Half of the enrolled study participants are given the study drug and half are given a placebo pill, to be taken twice a day for the duration of the study.
Participation in this study will last 18 months and will include approximately 11 study visits. Each participant will be asked to bring their study partner with them to visits.
Participants will be compensated for their time and effort.
Inclusion Criteria:
Exclusion Criteria: