A PILL FOR ALZHEIMER'S DISEASE? CLINICAL TRIALS ON A NEW APPROACH TO TREATING ALZHEIMER'S STARTS AT 50 MEDICAL CENTERS ACROSS THE COUNTRY

NIH-funded trial will evaluate the effects of a synthetic version of vitamin B1 on cognitive function that was developed by Burke Institute for people with early Alzheimer's disease

For more information about the trial and to find a study site, visit benfoteam.org

WHITE PLAINS, N.Y., Sept. 23, 2024 /PRNewswire/ -- A completely different approach to stopping the progression of Alzheimer's disease pioneered by a research institute based in Westchester County, NY is now being tested nationwide.

The Burke Neurological Institute (BNI), an affiliation of Weill Cornell Medicine, in partnership with the Alzheimer's Disease Cooperative Study (ADCS) at University of California San Diego and Columbia University Irving Medical Center, have launched a national clinical trial to investigate the therapeutic potential of a BNI and Weill Cornell Medicine-developed form of benfotiamine, a synthetic version of vitamin B1 (thiamine), as a treatment for mild cognitive impairment (MCI) and early Alzheimer's disease (AD).

The BenfoTeam trial (The Phase 2A-2B study) taking place at 50 sites across the U.S. will evaluate the effects of benfotiamine on cognitive function and whether high doses benefit people 50-89 with mild AD and MCI. The trial is funded by the National Institute on Aging (NIA), a part of the National Institutes of Health (NIH).

Benfotiamine is a synthetic drug which can increase blood thiamine up to 100 times the normal level. These levels of blood thiamine cannot be achieved by taking thiamine alone. The brain tissue in people with AD shows a thiamine deficiency, even with a sufficient supply of thiamine in a person's blood. The trial is investigating whether the delivery of thiamine via drug will increase the amount of thiamine getting to the brain and slow cognitive decline in people with early AD. Currently, 5.8 million Americans are living with AD with this number projected to rise to nearly 14 million people by 2050.

"The approach of using benfotiamine in patients with mild Alzheimer's is very promising," said Rajiv Ratan, M.D., Ph.D., Executive Director at Burke Neurological Institute. "This clinical trial builds on years of hard work to address a disease that affects millions of patients "

Howard Feldman, Director of the ADCS at UC San Diego said, "The launch of the BenfoTeam clinical trial represents a fresh approach with a potential treatment that is readily accessible, scientifically compelling, and cost-effective – that's a trifecta for a potential AD therapy in a Phase 2 trial – and benfotiamine has a strong safety profile."

Gary E. Gibson, Ph.D., Professor of Neurosciences at BNI, has spent decades conducting studies to better understand Alzheimer's disease and how to develop new therapies to treat the disease.

The BenfoTeam study builds on Gibson's scientific research conducted at Burke Neurological Institute – the only research institute in the U.S. dedicated to finding treatments to repair the brain and spinal cord. Gibson said many existing treatments or drugs in development only treat the symptoms of Alzheimer's disease such as amyloid plaques, but do not address the root cause of the disease. Benfotiamine has been shown to improve memory and diminish plaques, tangles, inflammation, and oxidative stress in animal models. In addition, unlike many of the other recently approved treatments for Alzheimer's disease, benfotiamine can be taken by mouth and does not require infusions.

"In people with Alzheimer's disease, reductions in brain glucose utilization track closely with cognitive decline and we already know that thiamine deficiencies can cause dementia," said Gibson, who is also a Professor of Neuroscience in the Feil Family Brain and Mind Research Institute at Weill Cornell Medicine. "We think people with mild cognitive impairment and Alzheimer's disease may not be getting enough thiamine delivered to the brain."

Jose Luchsinger, M.D., MPH, Vice-Chair for Clinical and Epidemiologic Research at Columbia University and a BenfoTeam trial co-Principal Investigator said, "While Alzheimer's disease impacts all aging populations, it is not clear that recently approved Alzheimer's therapies benefit underrepresented racial and ethnic groups. The BenfoTeam trial is designed for all patient populations.''

Participation in the trial for each patient will last 18 months (plus screening) and enrollment is planned for 406 participants.

For more information about the trial and to find a study site, visit benfoteam.org or call 877-807-1290 (toll free).

This research will be supported by the NIH's National Institute on Aging (R01AG076634). This content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH's National Institute on Aging.

The ClinicalTrials.gov ID number for this study is: NCT06223360.

About the BenfoTeam Partnership 
The BenfoTeam clinical research trial is funded by a grant from the National Institute on Aging (NIA) (R01AG076634). The clinical research trial is coordinated by the Alzheimer's Disease Cooperative Study (ADCS) at University of California San Diego School of Medicine and is led by principal investigators from the Burke Neurological Institute and Weill Cornell Medicine, Columbia University Irving Medical Center, and UC San Diego.

SOURCE Burke Neurological Institute

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