Note: I've been unable to find the research protocol described below. Here are two investigators who, I believe, are involved in the study:
Contacts
David Gould, M.D., Chief Operating Officer
Phone: 914.368.3172
Email: dag4015@med.cornell.edu
Website: burke.weill.cornell.edu
Gary E. Gibson, Ph.D.
Phone: 914.597.2291
Email: ggibson@med.cornell.edu
Website: burke.weill.cornell.edu
In this post, I link to and excerpt from a San Diego Today news report, Novel Treatment Approach to Alzheimer's Disease Uses Vitamin B1 Derivative, July 19, 2022.
All that follows is from the above resource.
With a $45 million grant from the National Institutes of Health and National Institute on Aging, the Alzheimer's Disease Cooperative Study (ADCS) at University of California San Diego, in collaboration with Burke Neurological Institute (BNI) and Columbia University Irving Medical Center, will launch 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.
The trial advances the ADCS mission to develop and test therapies to benefit those at risk or experiencing the symptoms of Alzheimer's disease (AD). ADCS will coordinate the multi-center trial to evaluate whether high doses of benfotiamine benefit people with mild AD or mild cognitive impairment due to AD (MCI).
The trial addresses tissue deficiency of thiamine-regulated metabolic pathways linked to AD. Previous work by co-principal investigator Gary E. Gibson, PhD, professor of neuroscience 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, Gibson and others have shown that increasing thiamine to very high levels using benfotiamine supplementation appeared to be protective against Alzheimer's-like symptoms. For the study, ADCS 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 benfotiamine study will monitor participants over 18 months, using several measures, including cognitive tests and blood markers that signal AD and MCI status and progression.
"At the Burke Neurological Institute, we have been studying the effects of thiamine on neurodegenerative diseases for more than 40 years," said Gibson. "This important grant will allow us to test the treatment with hundreds of Alzheimer's disease patients across the U.S. We are eager to begin this critical new stage of the research.
"I am particularly excited about this trial because it will determine how relevant these decades of research are to the treatment of Alzheimer's disease."
Joining Feldman and Gibson as a co-principal investigator in the new trial is José Luchsinger, MD, professor of medicine and epidemiology at Columbia University Irving Medical Center.
Additional academic laboratory collaborators include the University of Gothenberg, Sweden; University of Cambridge, UK; and Georgetown University, Washington, D.C. Another study partner is C2N Diagnostics, a St. Louis company focused on advanced brain health diagnostics.
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.
