[dropcap]T[/dropcap]he University of Miami Miller School of Medicine is participating in a new national Alzheimer’s disease clinical research study evaluating the potential benefits of an investigational medicine when taken by people with mild-to-moderate Alzheimer’s who are already being treated with donepezil (Aricept).
Titled NOBLE, the trial is evaluating an investigational drug, T-817MA, which may have the potential to modify the pace of the disease.
The advent of NOBLE comes at a time when the Alzheimer’s disease (AD) clinical research community is moving to prevention- oriented trials that do not 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 for the treatment of AD since 2003. The NOBLE study was launched potentially to help address this gap in treatment.
“The impact of Alzheimer’s disease both for sufferers and their loved ones is staggering,” said the principal investigator of the UM arm of the study, Clinton Wright, MD, MS, scientific director of the Evelyn F. McKnight Brain Institute, and the Evelyn F. McKnight Endowed Chair for Learning and Memory in Aging.
“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.”
Wright said. “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show significant decline in cognitive function, from forgetfulness about one’s personal history and becoming moody and withdrawn in social situations to an inability to identify the day of the week or their location. 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 the Miller School of Medicine are 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.
The University of Miami is one of 50 centers nationally participating in the NOBLE Study, a Phase 2 multi-center, randomized, double blind, placebo controlled, parallel group study. The duration of treatment is about 14 months. 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 six months, and have a study partner who has regular contact with the candidate and is able to attend study visits.
For additional information on the NOBLE study, visit www.NOBLEstudy.org or contact the Memory Disorders Center at the Miller School at 305-243-0184.