The link between Alzheimer’s disease and the tissue deficiency of thiamine-regulated metabolic pathways will be addressed in a new clinical trial.
A nationwide clinical trial to further investigate the therapeutic potential of benfotiamine, a synthetic version of thiamine (B1), as a metabolic treatment approach to Alzheimer’s disease (AD). This trial will be conducted by the National Institutes of Health and National Institute on Aging at the University of California San Diego, in collaboration with Burke Neurological Institute (BNI) and Columbia University Irving Medical Center.
‘New clinical trials are important for leading the way in looking at new possibilities for preventing and treating Alzheimer’s disease.’
More than 6 million Americans currently live with AD, a figure forecast to rise to nearly 13 million by 2050. Globally, the prevalence of AD is projected to grow from a current 57 million to 153 million in 2050. Currently, there is no cure for AD.Future of Alzheimer’s Disease Treatment
The trial will develop and test therapies to benefit those at risk or experiencing the symptoms of Alzheimer’s disease. First, it will evaluate whether high doses of benfotiamine benefit people with mild AD or mild cognitive impairment due to AD.Previous work at Brain and Mind Research Institute, part of Weill Cornell Medicine, has found that a reduction in glucose metabolism is linked to this deficiency in thiamine-dependent processes.
Using multiple experimental models, researchers have shown that increasing thiamine to very high levels using benfotiamine supplementation appeared to be protective against Alzheimer’s-like symptoms. For the study, they will enroll approximately 400 patients at up to 50 U.S.-based clinical trial sites, beginning in early 2023.
“We are excited to receive this funding, which will enable expanded testing of benfotiamine through to its clinical proof of concept, including adaptively testing for the optimal dose and treatment response across clinical and biomarker measures,” said Howard Feldman, MD, dean of Alzheimer’s Disease Research and professor of neurosciences at UC San Diego School of Medicine.
The study will monitor participants over 18 months, using several measures, including cognitive tests and blood markers that signal AD and MCI status and progression.
Treating Alzheimer’s Disease with New Drug Therapies
The trial highlights efforts to develop new interventional approaches. Benfotiamine is a good example of the treatment approach. If found to be beneficial, the treatment would be widely available and affordable.Advertisement
Even the recently completed EXERT study was a Phase III clinical trial to test whether physical exercise can slow the progression of mild memory loss and/or MCI in adults between the ages of 65 and 89. Results of the study will be presented at the Alzheimer’s Association International Conference in San Diego in late July.
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Source-Medindia