The University of Nebraska Medical Center is participating in a new Alzheimer’s disease (AD) clinical research trial (NOBLE), to evaluate the potential benefits of an investigational drug in mild-to-moderate AD patients who are already being treated with donepezil (Aricept).

The NOBLE 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.

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Initiation of this NOBLE trial 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.

The US Food and Drug Administration (FDA) has not approved any drug for the treatment of AD since 2003.

"The NOBLE 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."

UNMC Department of Neurological Sciences professor and the lead investigator on the clinical trial at UNMC Dr Daniel Murman said: "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.

"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 is developed when nerve cells in the brain no longer function normally, causing a change in one’s memory, behaviour and ability to think clearly.

The trial is designed to explore the potential of T-817MA, a neuroprotectant agent designed to protect against neuron loss.

Neuroprotectants are used for many central nervous system (CNS) disorders including stroke and Parkinson’s disease (PD).

UNMC is one of 50 centres nationally that will participate in the NOBLE trial, which is sponsored by Toyama Chemical, FUJIFILM Group, makers of T-817MA, and is being conducted by the Alzheimer’s Disease Cooperative Study (ADCS).

UNMC clinicians in consultation with family caregivers are now seeking eligible candidates for the NOBLE trial.

In order to participate in the trial, 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.