One of 50 U.S. centers participating in NOBLE Study
The University of Nebraska Medical Center 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).
Entitled NOBLE, the trial 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.
“The impact of Alzheimer’s disease both for sufferers and their loved ones is staggering, and 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,” said Daniel Murman, M.D., professor in the UNMC Department of Neurological Sciences and the lead investigator on the clinical trial at UNMC.
“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 their families in the future, and to advance the research around breakthrough therapy options for Alzheimer’s disease.”
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show significant decline in cognitive function, from forgetfulness about one’s personal history and becoming moody and withdrawn in social situations to an inability to identify the day of the week or where they are.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, UNMC clinicians 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.
UNMC is one of 50 centers nationally which 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 Alzheimer’s Disease Cooperative Study (ADCS), the largest Alzheimer’s disease therapeutic research consortium in the United States.
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 who has regular contact with the candidate and is able to attend study visits.
For further information on participating in the UNMC portion of the study, please contact Micki at (402) 552-6241. The Institutional Review Board number for the study is 221-14.