Protocol for a seamless phase 2A-phase 2B randomized double-blind placebo-controlled trial to evaluate the safety and efficacy of benfotiamine in patients with early Alzheimer's disease (BenfoTeam).

While group difference in change on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) did not reach statistical significance, there was a numerical benefit, with 43% less decline in benfotiamine (-1.39) vs placebo (-3.26) (mixed effect model p = 0.071, GEE p = 0.137, and non-parametric Wilcoxon rank sum test p = 0.098).

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