A study underway at 50 U.S. hospitals is taking an alternative approach in investigating how to slow the progression of Alzheimer’s disease— a condition that affects an estimated one in nine people age 65 and older, and one for which there is no cure. In the current research, scientists have created a pill meant to protect brain cells from dying off, which is a hallmark of Alzheimer’s disease.
The NOBLE Study, which is currently in its second phase, has a randomized, double-blind, placebo-controlled group model, and it is slated to last 14 months. Researchers are aiming to enroll 450 people ages 55 to 85 with mild to moderate Alzheimer’s disease. Participants will receive either a placebo or an investigational drug called T-817MA. The drug is designed as a neuroprotectant agent meant to prevent neuron loss. Study authors noted the drug is not meant to cure the disease but rather slow its progression.
“Instead of going after the Alzheimer’s disease, it goes after the metabolism of the brain cells, which is a really interesting approach,” principal study investigator Dr. Jeffery Burns, professor of neurology and co-director of the Alzheimer's Disease Center at the University of Kansas, told FoxNews.com.
According to the Alzheimer’s Association, two abnormal structures called plaques and tangles are prime suspects in damaging nerve cells. Plaques are deposits of the protein fragment beta-Amyloid that accumulate between nerve cells, and tangles are twisted fibers of another protein that build up inside the cells.
Burns said the drugs currently available to treat Alzheimer’s only address the symptoms, like memory loss, and not the root cause of the disease. What’s different about T-817MA, is it is designed to attack the potential cause of the disease in the metabolism of the brain cells rather than the Amyloid buildup.
A wealth of previous research has studied the link between Amyloid plaque buildup in the brain and the presence of Alzheimer's— and what happens when the protein is blocked or removed from the organ, Burns noted. However, early studies on this approach have failed
“The different, alternative approaches are increasingly important,” Burns said. “We need diversity, and this is one drug of a number of different approaches that we’re starting to see undergo human testing.”
For the NOBLE Study, interested candidates undergo an evaluation that includes a set of tests and questionnaires so researchers can better understand how far their Alzheimer’s has progressed. Prospective participants must also be prescribed and continue taking doses of either donepezil or rivastigimine, which are used to prevent acetylcholinesterase from breaking down acetylcholine in the brain to promote increased communication between nerve cells. After 14 months, participants undergo more memory testing, as well as brain scans to see if the group that received T-817MA fared better than the placebo group.
“If the drug modifies the disease process, that would be huge,” Burns said. “We don’t have drugs that would stop the disease process.”
Researchers hope to begin collecting results by next year.