{"id":45919,"date":"2022-07-07T16:01:57","date_gmt":"2022-07-07T14:01:57","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/burke-neurological-institute-receives-a-45-million-nih-grant-to-study-a-vitamin-b1-precursor-for-treatment-of-alzheimers-disease-in-multi-center-clinical-trial\/"},"modified":"2022-07-07T16:01:57","modified_gmt":"2022-07-07T14:01:57","slug":"burke-neurological-institute-receives-a-45-million-nih-grant-to-study-a-vitamin-b1-precursor-for-treatment-of-alzheimers-disease-in-multi-center-clinical-trial","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/burke-neurological-institute-receives-a-45-million-nih-grant-to-study-a-vitamin-b1-precursor-for-treatment-of-alzheimers-disease-in-multi-center-clinical-trial\/","title":{"rendered":"Burke Neurological Institute Receives a $45 Million NIH Grant to Study a Vitamin B1 Precursor for Treatment of Alzheimer\u2019s Disease in Multi-center Clinical Trial"},"content":{"rendered":"
\n

WHITE PLAINS, N.Y.–(BUSINESS WIRE)–The Burke Neurological Institute (BNI) has received a five year award expected to total $45 million from the National Institutes of Health (NIH) to launch a large-scale, multi-center clinical trial to evaluate benfotiamine, a synthetic precursor of thiamine (vitamin B1), as a potentially effective therapy for mild Alzheimer\u2019s disease (AD) or mild cognitive impairment (MCI). This follow-up trial will expand on previous work completed at BNI, suggesting that high levels of benfotiamine significantly slowed the rate of functional decline in participants with mild cognitive impairment or early AD.\n<\/p>\n

<\/a>
<\/a><\/p>\n

\n\u201cIt is gratifying to see research which the Alzheimer\u2019s Drug Discovery Foundation initially identified as promising and supported in a pilot study continue to be pushed forward with funding from the NIH\u2019s National Institute on Aging<\/a>,\u201d said Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer\u2019s Drug Discovery Foundation<\/a> (ADDF). \u201cWith the improved biomarkers that have been developed since the pilot, this next phase will provide a deeper understanding of how benfotiamine works in the brain. Novel approaches that target the many biological factors which contribute to Alzheimer\u2019s, like metabolic dysfunction, are essential to finding effective treatments for this disease.\u201d\n<\/p>\n

\nDysfunction in the brain\u2019s ability to metabolize glucose is a known marker of AD and other dementias and can begin decades before a person has clinical symptoms or memory loss. Previous work by Burke Neurological Institute\/Weill Cornell Medicine<\/a> researcher Dr. Gary E. Gibson<\/a>, who will also be a leader of the upcoming clinical trial, suggested that reduction in glucose metabolism is due to a decline in thiamine-dependent processes. Using multiple experimental models, he and others have shown that increasing thiamine to very high levels via benfotiamine was protective against Alzheimer\u2019s-like symptoms. Dr. Gibson noted, \u201cI am particularly excited about this trial because it will determine how relevant these decades of research are to the treatment of Alzheimer\u2019s disease. If our hypothesis is correct, we will advance an exciting investigative clinical treatment pathway relevant for millions of patients, and with potential advantages in safety and value.\u201d\n<\/p>\n

\nThese foundational experiments led to a recent pilot study, published<\/a> in the Journal of Alzheimer\u2019s Disease<\/i> in 2020 and carried out by Dr. Gibson along with research partners at Weill Cornell Medicine, Burke Rehabilitation Institute, and Columbia University Irving Medical Center. The study suggested a slowed rate of cognitive decline in 35 participants with mild MCI or early AD who took 300-mg benfotiamine pills twice daily, and the treatment was completely safe.\n<\/p>\n

\nThe larger upcoming clinical trial will be carried out in collaboration with leading researchers in AD and related dementias; Dr. Howard Feldman<\/a>, director of the Alzheimer\u2019s Disease Cooperative Study (ADCS)<\/a> at the University of California, San Diego and Dr. Jose Luchsinger<\/a>, investigator at Columbia University Irving Medical Center. \u201cWe are excited to receive this funding which will enable the further 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,\u201d said Dr Feldman. Dr. Luchsinger stated \u201cI have been conducting research to understand the metabolic contributions to AD for 20 years and believes that understanding the role of thiamine in AD is an important step in this field.\u201d\n<\/p>\n

\nEnrolling roughly 400 patients in up to 50 US-based clinical trial sites, with study coordination by the ADCS, will support the new study to be among the first to select patients and follow progression over 18 months, using several measures, including cognitive tests and blood markers that signal AD and MCI status and progression. The trial will provide a larger and more robust evaluation of benfotiamine\u2019s potential use in treating AD by following cognitive measures as well as a number of blood markers that reflect the brain\u2019s glucose use, neuron loss, inflammation, and even aspects of brain pathology. These promising blood markers to track AD progression have themselves been under investigation for many years and represent the cumulative work of researchers across the globe.\n<\/p>\n

\nAdditional academic institutions partnering with BNI to support this trial include the University of Gothenberg (Gothenberg, Sweden), the University of Cambridge (Cambridge, United Kingdom) and Georgetown University (Washington, DC). BNI is also pleased to collaborate with C2N Diagnostics (St. Louis, MO), a company focused on advanced brain health diagnostics.\n<\/p>\n

\nThere is enormous unmet need regarding both treatment and prevention of AD in the growing and aging population. More than six million Americans are living with AD, which is forecasted to rise to nearly 13 million by 2050. Globally, the prevalence of AD is projected<\/a> to rise from 57 million to 153 million in 2050. There is no true cure for the disease and no effective treatments exist. Clinical trials over the last decade have frequently failed, and the most recently approved therapy has been met with controversy regarding efficacy, safety, value and pricing. Treatments for AD and MCI that are effective, safe, and affordable are critically needed across the globe.\n<\/p>\n

\nEnrollment of trial participants is expected to begin in the first quarter of 2023.\n<\/p>\n

\nThe Phase II randomized controlled trial of benfotiamine in early Alzheimer’s Disease is funded by NIH grant R01AG076634.\n<\/p>\n

\nThe content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.\n<\/p>\n

\nAbout Alzheimer\u2019s Disease Cooperative Study:<\/b>\n<\/p>\n

\nThe Alzheimer\u2019s Disease Cooperative Study (ADCS) is an academic research organization located at UC San Diego which is dedicated to developing treatments for those at risk or affected by Alzheimer\u2019s disease. For upwards of 30 years, with funding including the National Institute on Aging, it has been a field leader in progressing potential new treatments through innovation in clinical trials with design, methods, and analytics. It has a trials coordinating center in San Diego and a network of participating sites across the United States.\n<\/p>\n

\nAbout Alzheimer\u2019s Drug Discovery Foundation<\/b>\n<\/p>\n

\nFounded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer’s Drug Discovery Foundation (ADDF) is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer’s disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer’s, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, the ADDF has awarded more than $209 million to fund over 690 Alzheimer’s drug discovery programs, biomarker programs and clinical trials in 19 countries. To learn more, please visit: http:\/\/www.alzdiscovery.org\/<\/a>.\n<\/p>\n

\nAbout Burke Neurological Institute<\/b>\n<\/p>\n

\nThe Burke Neurological Institute<\/a> is based in White Plains, NY, and was established in 1978 by Dr. Fletcher McDowell as a research institute dedicated to finding cures for chronic neurological disabilities. The Institute transforms groundbreaking research into clinical treatments so that people can see, talk, and walk again. Their goal is to combine the most rigorous, contemporary brain science with heartfelt compassionate care to innovate and develop novel cures for stable disability in those afflicted with neurological conditions such as stroke, traumatic brain injury or spinal cord injury. Burke Neurological Institute is an academic affiliate of Weill Cornell Medicine.\n<\/p>\n

Contacts<\/b> <\/p>\n

\nDavid Gould, M.D., Chief Operating Officer
\n
Phone: 914.368.3172
\n
Email: dag4015@med.cornell.edu<\/a>
Website: burke.weill.cornell.edu<\/a>\n<\/p>\n

\nGary E. Gibson, Ph.D.
\n
Phone: 914.597.2291
\n
Email: ggibson@med.cornell.edu<\/a>
Website: burke.weill.cornell.edu<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

WHITE PLAINS, N.Y.–(BUSINESS WIRE)–The Burke Neurological Institute (BNI) has received a five year award expected to total $45 million from the National Institutes of Health (NIH) to launch a large-scale, multi-center clinical trial to evaluate benfotiamine, a synthetic precursor of thiamine (vitamin B1), as a potentially effective therapy for mild Alzheimer\u2019s disease (AD) or mild … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-45919","6":"format-standard","7":"category-industry"},"yoast_head":"\nBurke Neurological Institute Receives a $45 Million NIH Grant to Study a Vitamin B1 Precursor for Treatment of Alzheimer\u2019s Disease in Multi-center Clinical Trial - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/burke-neurological-institute-receives-a-45-million-nih-grant-to-study-a-vitamin-b1-precursor-for-treatment-of-alzheimers-disease-in-multi-center-clinical-trial\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Burke Neurological Institute Receives a $45 Million NIH Grant to Study a Vitamin B1 Precursor for Treatment of Alzheimer\u2019s Disease in Multi-center Clinical Trial - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"WHITE PLAINS, N.Y.–(BUSINESS WIRE)–The Burke Neurological Institute (BNI) has received a five year award expected to total $45 million from the National Institutes of Health (NIH) to launch a large-scale, multi-center clinical trial to evaluate benfotiamine, a synthetic precursor of thiamine (vitamin B1), as a potentially effective therapy for mild Alzheimer\u2019s disease (AD) or mild ... 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