A new proposed drug to combat Alzheimer's disease, one of the leading causes of death in America, is ready for trials to gauge its effectiveness, U.S. researchers say.
Scientists at Boston University Alzheimer's Disease Center and Boston Medical Center say several trials will be conducted in order to observe the effects of a newly developed drug known as T-817MA.
T-817MA aims to actively alter the course of the disease to help people already suffering with dementia, making it different from current medications which are used to slow the early symptoms that come with the onset of Alzheimer's, the researchers point out.
If the trials lead to approval of T-817MA by the U.S. Food and Drug Administration, it will be the first Alzheimer's drug approved since 2003.
"The changes in the brain in Alzheimer's disease start maybe 20 years before the first symptoms and then get worse and worse as the disease gets further along," notes Dr. Robert Stern of the Alzheimer's Disease Center.
If the drug displays positive results in trials then it can offer hope of slowing down that progression, helping a person with Alzheimer's maintain a much-improved quality of life without deterioration, he says.
T-817 has successfully passed a first phase of testing, demonstrating it is safe for trial testing on larger groups of patients, and will begin Phase 2 trials this years, the researchers say.
"In my mind, right now, in all the studies that are going on, this is one of the most, if not the most promising approach to try to slow down the disease in someone who is already at the point of having moderate stages of dementia," Stern says.
Presently there are only five FDA-approved drugs for treating Alzheimer's, which affects nearly 5 million Americans presently and is predicted to strike as many as 15 million in the next 5 years as America's aging population grows.
Alzheimer's, a neurodegenerative disease accounting for more than 60 percent of all dementia, is the sixth leading cause of death in the United States.
One problem the trials for T-817MA may come up against is finding enough Alzheimer's patients to participate, Stern says, since the disease if often unnoticeable in its earliest stages of minor memory loss issues, and therefore difficult to diagnose.
"It is in general a tremendous problem nationwide to recruit an adequate number of people to participate in Alzheimer's studies," he says.
Still, he says, trials of new drugs such as T-817MA are important, since they show promise of "truly modifying the disease course, and clinically you're preventing it."