Neuronix Ltd., which develops an Alzeihmer's treatment which integrates brain stimulation with cognitive exercises, reports partial success in its multi-center clinical trial involving 131 patients.
The company's results were conclusive in one of two accepted scales for Alzeihmer's Disease severity (ADAS-Cog) in patients in early and middle stages of the disease. When the entire research population was examined, including severe condition patients, results were inconclusive. According to one accepted Alzheimer's Disease severity scale, results indicated an improvement, but were inconclusive, neither in early stage patients nor in the general research sample.
In terms of safety, results were good. None of the participating patients experienced severe negative effects related to the research and only in a few cases the treatment was stopped in the middle of the trial.
A few months ago, the company reported a successful trial involving 30 patients, and now the full trial results have arrived.
Based on these figures, Neuronix plans to submit the system for US marketing approval and estimates that it will receive a permit for treatment of early-middle stage patients. The company has already received US Food and Drug Administration (FDA) consent to fast track its application, as a company offering innovative solutions to terminal diseases.
At present there is no effective treatment for Alzheimer's and the community of practitioners in this field is gradually coming to agree that the disease itself, and primarily its late stages, will be difficult to treat, and perhaps it will only be possible to delay its development if diagnosed in its early stages. Therefore, Neuronix's optimism that it will receive a marketing permit is in place, even though its treatment was only proven effective in early stages of the disease.
Neuronix's system generates brain stimulation using a magnetic field; once the brain is stimulated, the patient solves exercises on the company's computer system. Cognitive exercises are known as effective Alzheimer treatment and Neuronix's working assumption is that when the brain is stimulated, it is easier to sustain changes resulting from the exercises.
Dr. Marwan N. Sabbagh, who headed one of the trial's research centers, "the research has shown that treatment with neuroAD is characterized by very light side effects, which pass on their own and that the treatment can be accompanied with a continuation of existing drug treatment. The research is also indicative of neuroAD's potential to improve the patients' cognitive capabilities, while also improving their day-to-day functioning, specifically in groups which are clinically well-defined in the early stages of the diseases.
"Once FDA approval is received, neuroAD will become a powerful tool in the fight against Alzheimer's Disease, which, at present, is being fought almost with our bare hands."
Neuronix was founded in 2008 and focuses on Alzheimer's Disease treatment. The company, managed by CEO Eyal Bar-Or, has raised $15 million from private investors.
Published by Globes [online], Israel business news - www.globes-online.com - on December 20, 2016
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