Alzheimer’s Treatment Considered by FDA for Approval

A device created by an Israeli company to treat Alzheimer’s disease was considered for approval in the United States this week.

According to IEEE Spectrum, “an FDA advisory committee” met on Thursday “to discuss the NeuroAD machine, which generates an electric current inside the patient’s brain while the patient engages in cognitive training tasks.”

“The device, from the Israeli company Neuronix, is already approved for medical use in Israel and Europe. If the advisory panel recommends U.S. approval, the result is still uncertain; the FDA isn’t bound by the committee’s recommendation,” IEEE Spectrum explained.

In a statement, Neuronix CEO Eyal Baror proclaimed, “We appreciate the thoughtful consideration of the neuroAD data as well as the needs of the Alzheimer’s disease community of patients and caregivers. We are pleased that the committee recognized the safety of the device, but we are disappointed that the panel’s feedback on our clinical studies and data analysis may result in neuroAD not being available in the US in the foreseeable future.”

“We plan to engage with the FDA to discuss a path forward to ensure that US patients have the same access to this treatment as is enjoyed by Alzheimer’s sufferers in over 30 other countries,” Baror continued. “On a day when yet another Alzheimer’s drug trial was curtailed, we believe that this device offers a safe and effective nonpharmacologic solution to patients in need and are appreciative that the committee saw our data as a positive signal toward next steps.”

Harvard Medical School professor Alvaro Pascual-Leone declared, “I hope that the panel will agree that there is a big need, and that there is good evidence that a sub-population of patients derive benefit from this intervention.”

Pascual-Leone added that the technology “opens up the possibility of priming brain networks, and making them more receptive to intervention.”

“It’s crucial to match the brain area targeted with the appropriate cognitive training,” he expressed. “That’s essential. Otherwise you’re activating the brain network but not engaging it.”

On Neuronix’s website, the company described the device as “a novel, non-invasive medical device which has helped many Alzheimer’s Disease patients achieve sustained cognitive improvement.”

Neuronix also claimed that it “is typically combined with Alzheimer’s Disease medication, and offers new hope for patients to enjoy better quality of life.”