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 (BENFO-TEAM)

Grants and Contracts Details

Description

Alzheimer’s disease (AD) is a progressive neurologic disorder that is the most common cause of dementia with devastating socioeconomic implications. More than 5 million people are afflicted with AD and related dementias in the United States, and by 2050 this number could rise as high as 16 million, with annual costs of over $1 trillion [1]. The emotional and financial burden of AD to patients, family members, and society is enormous, and is predicted to grow exponentially as the median population age increases. The potential to preserve, or even improve, cognition in adults at high risk of cognitive decline due to AD clearly has important implications, not only for the affected individual, but also for the support system that bears the social and financial burdens of long-term caregiving. Benfotiamine provides an important novel therapeutic direction in AD that has potential for additive or synergistic effects beyond current mainstream approaches. It has a unique mechanism of action, raising blood thiamine 50-100 times to pharmacological levels. In AD, it addresses and treats a well-characterized tissue thiamine deficiency and related changes in glucose metabolism as well as post-translational modifications including plaque [2] and tangle formation [3], neuroinflammation [4, 5], neurodegeneration [6], and advanced glycation end products (AGEs) [7]. Importantly, it further addresses the US National Alzheimer’s Project Act (NAPA) therapeutic goal of combining targets [8].
StatusActive
Effective start/end date7/1/226/30/24

Funding

  • University of California San Diego Health: $2.00

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