An Israeli company is still working to get a medical device it says treats and potentially cures Alzheimer’s disease to be approved for use in the United States.
According to Reuters, Neuronix developed a non-invasive medical device to treat Alzheimer’s in 2012 and expected the U.S. Food and Drug Administration to approve it for use in 2014. In addition to Israel, the device is approved for use in Europe and several Asian countries.
The Neuronix device, called neuroAD, uses a combination of electromagnetic stimulation and computer-based cognitive training. It has advanced to the third stage of FDA approval. Patients sit in a chair with a built-in computer and electronic system and have a coil placed on their head. Hourly treatments are administered five days a week for six weeks.
According to Neuronix, the stimulation targets brain regions responsible for the cognitive functions that Alzheimer’s impairs. It also induces long-term potentiation, which the company said makes brain regions associated with learning and memory more receptive to cognitive training.
According to the Neuronix website, neuronixmedical.com, there are eight sites for ongoing clinical trials in the U.S. and Israel, including the Lou Ruvo Center for Brain Health, part of the Cleveland Clinic, in Las Vegas; the Palm Beach Neurology and Premiere Research Institute, in West Palm Beach, Fla.; Beth Israel Deaconess Medical Center, in Boston; Banner Sun Health Research Institute, in Sun City, Ariz.; NYU Langone Medical Center, in New York; the Cleveland Clinic; Miami Jewish Health Systems, in Miami; Asaf Harofe Hospital, in Be’er Ya’akov, Zrifin, Israel; and ATP Clinical Research, in Costa Mesa, Calif.
On its website, Neuronix quotes Dr. Alvaro Pascual-Leone, of the Beth Israel Deaconess Medical Center at Harvard Medical School, in support of neuroAD.
“It doesn’t cure the disease, but it does make the brain circuits work better, and this leads to a striking improvement in cognitive abilities for day-to-day tasks,” said Pascual-Leone.
The company said evidence shows that the device brings not just short-term benefits to Alzheimer’s patients, but also prevents further deterioration of cognitive ability for up to a year. It also reports that neuroAD can be used in conjunction with Alzheimer’s medication and has not been known to lead to serious side effects.
“We see improvement lasting for nine to 12 months and the good thing is that patients can return and undergo treatment again,” Neuronix CEO Eyal Baror told Reuters in 2012. “If out of 10 years the patients have left to live we can keep them at home in a relatively mild state of the disease for three, four, five years, it’s a lot.”
