ELYRIA - Alzheimer's Disease is devastating to those suffering from it, and the family and friends around them.
But a clinical trial taking place in Northeast Ohio may offer new hope for relief for the first time in more than a decade.
There is no cure for Alzheimer's disease, which causes issues with memory, thinking and behavior to the point of patients no longer being able to perform daily tasks. Current treatments have limited benefit, and there have been no new drugs for the disease since 2003.
"Alzheimer's is a major public health problem," said Dr. Alan Lerner, director of the Brain Health and Memory Center, Neurological Institute Chair for Memory and Cognition, and staff neurologist at University Hospitals Cleveland Medical Center and professor at Case Western Reserve University School of Medicine. "Nearly 6 million people in the United States and 220,000 in Ohio are diagnosed with Alzheimer's. A lot of effort has been put into trying to prevent Alzheimer's recently, which is a laudable goal, but that shift means there is less funding for research for those who already have the disease. If this was any other disease, that would be completely unacceptable, and it is."
The study is sponsored by New Haven, Connecticut-based Biohaven Pharmaceutical Holding Company Ltd., and is coordinated by the Alzheimer's Disease Cooperative Study, a large clinical research consortium, based at the University of California, San Diego.
The T2 Protect AD study is a randomized, controlled clinical study to evaluate the drug troriluzole, a
third-generation pro-drug of the FDA approved drug, riluzole, in people with mild to moderate Alzheimer's, according to the ADCS. A pro-drug is an inactive medication that changes into a drug after ingestion.
The study is designed to determine if troriluzole can protect against or slow down progression of the disease and potentially improve memory and thinking problems that increase as AD progresses, according to the ADCS. It is hoped that troriluzole will reduce synaptic levels of glutamate in the brain. Glutamate problems in the brain can lead to brain cell dysfunction and disease, including Alzheimer's.
The drug is a modified version of a currently FDA-approved treatment for amyotrophic lateral sclerosis (ALS), riluzole. Researchers know that troriluzole, as compared to riluzole, is better able to reach the brain, potentially improving treatment options, the ADCS said.
University Hospitals is one of 30 facilities across the country in the study.
Lerner hopes to have 10 to 15 patients from around the Cleveland area, including Lorain County, participate.
The screening process is in its earliest stages, he said.
Nationwide, there will be nearly 300 participants in the clinical study, which could be completed as soon as February 2020.
"We're hoping to see, the best scenario, we would love to see people get better," Lerner said. "If not better, we would also hope to see that people stayed the same on the drug, whereas people on the placebo would get worse."
Men and women ages 50 to 85 are eligible for the clinical trial. They cannot live in a nursing home, and most have contact with someone three to four times a week who would be willing to work with them throughout the trial and accompany them to appointments to discuss progress and abilities. The trial lasts 48 weeks.
No cost is associated with participating.
Anyone interested in signing up may call (216) 464-6474, or visit t2protect.org.
"We are hoping this drug truly makes a difference in slowing progression of this illness," Lerner said. "It's a unique compound that takes a different approach than most recent drugs. Riluzole has shown efficacy in ALS patients, and the pro-drug now offers the possibility of helping those with Alzheimer's, and with fewer side effects."
Lerner has been on board with the Alzheimer Disease Co-op since its genesis in the early 1990s.
"To me, the most interesting thing about the brain is its ability to remember and to do things," the neurologist said. "Alzheimer's is the most common adult disorder to disrupt that."
Of course, the clinical study cannot happen without volunteers.
"That's true for almost every medication you take," he said. "It goes through a similar approval process. These are all dependent on volunteers. Safety is our highest concern. The two things we want to know are: does it work and is it safe."