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Pennington Biomedical Helping Lead National Study Evaluating New Approach That Could Slow Progression of Alzheimer's DiseaseNOBLE Study at Pennington Biomedical’s Institute for Dementia Research & Prevention Could Offer Hope for People with Mild-to-Moderate AD
Released: Thursday, September 18, 2014
BATON ROUGE, LA — Today LSU’s Pennington Biomedical Research Center announced that it is participating in a new national, Alzheimer’s disease (AD) clinical research study evaluating the potential benefits of an investigational medicine when taken by people with mild-to-moderate AD who are already being treated with donepezil (Aricept).
“Being selected as a site for this study is a real milestone for Pennington Biomedical’s Institute for Dementia Research and Prevention (IDRP). This distinction makes us as an official affiliate of the Alzheimer’s Disease Cooperative Study Group (ADCS) - the largest Alzheimer’s therapeutic research consortium in the U.S.,” said Dr. Jeffrey Keller, director of the IDRP at Pennington Biomedical. “The ADCS is leading federal efforts to find a cure for Alzheimer’s. It is an honor to have our site included ADCS studies, and NOBLE is our inaugural collaboration.”
The study is entitled NOBLE, and is evaluating an investigational drug, T-817MA, which may have the potential to modify the pace of the disease in those who are currently suffering with mild-to-moderate AD. The advent of NOBLE comes at a time when the AD clinical research community is moving to prevention-oriented trials that don’t include those already diagnosed with the disease. An estimated five million people in the U.S. already suffer from mild-to-moderate AD, with those numbers growing at an alarming rate. However, no new drug has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of AD since 2003. The NOBLE study was launched to potentially help address this gap in treatment.
“Alzheimer’s has a staggering impact on both disease sufferers and on their loved ones. Many people living with mild-to-moderate AD may feel left behind when it comes to options that could slow the pace of the disease,” added Dr. Keller. “We are proud to take part in this important study to evaluate a treatment that may contribute to changing the game for people suffering with AD and advance research on breakthrough therapy options.”
AD develops when nerve cells in the brain no longer function normally, causing a change in one’s memory, behavior and ability to think clearly. The NOBLE study will explore the potential of T-817MA, a neuroprotectant agent designed to protect against neuron loss. Neuroprotectants are used for many central nervous system disorders including stroke and Parkinson’s disease.
During the mild-to-moderate stage, people with AD begin to show significant decline in cognitive function, from forgetfulness about one’s personal history and becoming moody and withdrawn in social situations to an inability to identify the day of the week or where they are. As a result of this decline, sufferers with mild-to-moderate AD often require round the clock care.
In consultation with family caregivers, clinicians at Pennington Biomedical’s Institute for Dementia Research & Prevention are now seeking eligible candidates for NOBLE. Potential volunteers should live with or be in regular contact with a partner or family caregiver who can assist with their consideration of participation and accompany them to study visits.
Pennington Biomedical’s Institute for Dementia Research & Prevention is one of 50 centers nationally who will participate in the NOBLE Study. The study is sponsored by Toyama Chemical Co., Ltd., FUJIFILM Group, makers of T-817MA, and is being conducted by the ADCS. To be eligible to participate, people must be between 55 and 85 with mild-to-moderate Alzheimer’s disease, have been taking donepezil (Aricept®) for at least 6 months, and have a study partner that has regular contact with the candidate and is able to attend study visits.
The Pennington Biomedical Research Center is at the forefront of medical discovery as it relates to understanding the triggers of obesity, diabetes, cardiovascular disease, cancer and dementia. It is a campus of Louisiana State University and conducts basic, clinical and population research. The research enterprise at Pennington Biomedical includes approximately 80 faculty and more than 25 post-doctoral fellows who comprise a network of 44 laboratories supported by lab technicians, nurses, dietitians, and support personnel, and 13 highly specialized core service facilities. Pennington Biomedical’s more than 500 employees perform research activities in state-of-the-art facilities on the 222-acre campus located in Baton Rouge, Louisiana.