Israeli Medical Device Offers New Alzheimer's Treatment

Israeli Medical Device Offers New Alzheimer's Treatment

Expected for FDA Approval in Late 2014

November 6, 2012
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Israel-based Neuronix, which has developed a non-invasive medical device to help to treat Alzheimer's disease, expects the system to be approved by the U.S. Food & Drug Administration in late 2014.

The device, which combines electromagnetic stimulation with computer-based cognitive training, is already approved for use in Europe, Israel, and several Asian countries. In Singapore it is approved for clinical trial use and the application for registration of the product is still under evaluation.

"You stimulate the brain on a biological level as well as on a cognitive level," Neuronix CEO Eyal Baror tells Reuters, saying this double approach created longer-lasting benefits.

The device, which consists of a chair containing an electronic system and software in the back and a coil placed at the head, has been tested on mild to moderate Alzheimer's patients who suffer from dementia but are not totally dependent.

The system is in trials at Harvard Medical School/Beth Israel Deaconess Medical Centre. Patients are treated for one hour a day, five days a week over six weeks.

"We see improvement lasting for 9-12 months and the good thing is that patients can return and undergo treatment again," Baror says. "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."

According to Alvaro Pascual-Leone, director of the hospital's Berenson-Allen Centre for Non-invasive Brain Stimulation, brain stimulation - or transcranial magnetic stimulation - involves a very low current applied to a specific part of the brain and is approved by the FDA for treatment of a variety of ailments and diagnostic applications.

"The application in Alzheimer's disease and in combination with cognitive training is novel," Pascual-Leono says.

About 20% of patients experience a mild headache but there are no long-term negative effects, he says.

Pascual-Leone, who is principal investigator in the Harvard trial, says that of 12 patients in the study, six received the real treatment and all showed cognitive improvement. Their improvement was significantly more than the average seen in patients taking just medication, he says.

The study's results will be submitted for publication in the coming weeks and a follow-up study on 30 patients is planned.

Excerpted from an article by Tova Cohen. Click here to read the full story at Reuters.