Patients sought for U.S. nationwide study of drug that may slow Alzheimer's disease

Specifically, the trial will explore the potential of T-817MA, a drug designed to protect against the loss of nerve cells seen in AD. The study drug is a"neuroprotectant"- a class of drugs that prevents cell death and promotes neuronal regeneration by several mechanisms, including alleviation of oxidative stress.

Called the NOBLE study, the trial will be conducted jointly by Mount Sinai and the Alzheimer's Disease Cooperative Study, the largest Alzheimer's disease research consortium in the United States. Patients must already be taking the medication donepezil (an FDA-approved medication commonly used for the treatment of Alzheimer's disease) to qualify for the trial.

About 5 million Americans already suffer from mild-to-moderate AD, and the numbers are growing quickly. Despite this trend, no new AD drug has been approved by the U.S. Food and Drug Administration since 2003.

"NOBLE is recruiting at a time when the Alzheimer's disease research community is moving toward prevention-oriented trials, which involve subjects who may be at risk for developing the disease. Advanced diagnostic procedures and the development of biomarkers for the disease are enabling clinicians to identify these patients while there may be opportunity to prevent it from developing." says Amy Aloysi, MD, MPH, lead site investigator and assistant professor of neurology and psychiatry at the Icahn School of Medicine at Mount Sinai. "While our study focuses on whether T-817MA is safe, tolerable and has any potential to alleviate the symptoms in those already diagnosed with Alzheimer's disease, we are also hopeful about how the findings may contribute to future research."

Alzheimer's disease develops when nerve cells in the brain no longer function normally, causing changes in memory, behavior and ability to think clearly. In mild-to-moderate AD, patients begin to experience forgetfulness, mood swings and social withdrawal, and may need round-the-clock care.

The NOBLE study is a Phase-2, randomized, double blind, placebo-controlled, study, which means participants will not know whether they are receiving the study drug or a placebo. While participants may help with the goal of aiming to find new treatments for AD, participating in this study of a non-FDA approved medication may not have any direct benefit to participants. All of the procedures are being performed for research purposes, not clinical care.

Participation time for those who enroll in the study is about 14 months, which includes screening, one year of study treatment and follow up. Study participants will be seen by researchers every four weeks for the first three months, then every six to eight weeks for the next nine months, with a follow up visit four weeks later. Cognitive and physical evaluations and blood testing will be conducted at each visit and an MRI scan of the brain will be performed at the beginning and end of the study.

To participate, patients must be between 55 and 85 years of age with mild-to-moderate Alzheimer's disease, who have been taking donepezil (Aricept ®) for at least six months. They must also have a study partner with whom they have regular contact and who can attend study visits with them.

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 in conjunction with 50 research sites across the country.