First Device to Treat Alzheimer's Is Up for Approval by the FDA

Image: Neuronix

Update: The FDA did not approve the device. See end of article for details. 

The first medical device to treat the symptoms of Alzheimer’s disease is up for approval in the United States. This Thursday, an FDA advisory committee will meet 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.

“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,” says Alvaro Pascual-Leone, a professor of neurology at Harvard Medical School. As director of the Berenson-Allen Center for Noninvasive Brain Stimulation at Beth Israel Deaconess Medical Center, Pascual-Leone also led a clinical trial of the NeuroAD.

The big need, at least, is clear. In countries with aging populations, Alzheimer’s disease is becoming a crisis. Just look at the trend line in the United States: In 2010, an estimated 4.7 million people over the age of 65 were living with Alzheimer’s dementia. By 2050, that number is projected to rise to 13.8 million.

So far, pharmaceutical companies haven’t found the answer: Only a few drugs exist to help people with cognition and memory, and the improvements they offer are modest. No drug has yet been approved that slows the progress of the disease. About 150 attempts to develop new drugs have failed over the past decade. There have also been technological failures: A company called Lumos Labs, which promised that its online brain training games would stave off dementia, was fined $50 million for false advertising.

In Neuronix’s system, a patient sits in a chair to receive a regimen of transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique that’s commonly used today as a treatment for depression. Simultaneously, the patient does cognitive training exercises related to language, visual memory, spatial memory, and comprehension. The treatment, which lasts for six weeks, requires 1-hour sessions five days per week.

Neuronix CEO Eyal Baror says the recent clinical trial and several other studies have demonstrated that the device provides “meaningful improvement” to Alzheimer’s patients with mild to moderate symptoms. In the studies, patients have had an easier time finding words, remembering things, and completing the activities of daily life. These improvements in cognitive function have been shown to last for up to one year, Baror says, after which the benefits fade away.

There’s a possibility that patients could use the NeuroAD repeatedly, perhaps once a year, to give them a few more years of improved function and independence. Baror says some patients in Europe have already elected to follow this course of treatment, but he stresses that the efficacy of repeated treatments hasn’t been tested yet, and that NeuroAD hasn’t yet been proven to stabilize patients over a long span of time.

Baror says the failure of so many drug trials shows the need for another approach. Most of those drugs tried to clear away the plaques and tangles of protein that appear in the Alzheimer’s brain, in hopes of halting or even reversing the course of the disease. The NeuroAD doesn’t target these (presumed) biological causes of Alzheimer’s, but instead helps the brain work better despite its deterioration.   

“For a tough disease like Alzheimer’s, this is a really important tool,” says Baror. “We’re not attempting to cure Alzheimer’s, unfortunately, but we’re attempting to modify the course of the disease.”

TMS systems use an electromagnetic coil to generate a magnetic field, which, via electromagnetic induction, creates an electric current inside the brain. In the NeuroAD system, the coil is moved around to stimulate six different brain regions, including two parts of the cortex that are linked to speech (Broca’s area and Wernicke’s area). 

Pascual-Leone explains that TMS works by increasing the brain’s “plasticity,” thus improving its ability to strengthen connections between neurons and brain regions. “This opens up the possibility of priming brain networks, and making them more receptive to intervention,” he says.

By stimulating brain networks related to cognitive function, while simultaneously having patients perform training tasks that use those brain networks, the patient can strengthen the neural connections of that network. “It’s crucial to match the brain area targeted with the appropriate cognitive training,” says Pascual-Leone. “That’s essential. Otherwise you’re activating the brain network but not engaging it.”

Neuronix got into trouble in the United Kingdom last year, when the UK Advertising Standards Agency ruled that the company had gone too far with an ad that described the NeuroAD as “a new treatment for Alzheimer’s disease.”

James Pickett, head of research for the London-based Alzheimer’s Society, told IEEE Spectrum that his group is wary of new interventions that claim to treat dementia. “Last year, the Advertising Standards Authority took action to stop unsubstantiated claims about Alzheimer’s treatments, as there simply wasn’t enough evidence for this particular therapy to recommend it,” he said in an email. “We are not aware of what new evidence has been generated as it is yet to be made available in the public domain, so we’re neutral on the approval and will study the FDA conclusions with interest.”

Pascual-Leone says it’s good to be skeptical, particularly because so many approaches to Alzheimer’s treatment have failed. “On the other hand, we all feel the urgency; this is a devastating disease for the patient, the family, and society as a whole,” he says. “There’s a real need for something that can help.” 

Update: The FDA panel voted unanimously that Neuronix has not proven the efficacy of its device. In an FDA report prepared for the meeting, the panel expressed uncertainty about the clinical trial methodologies and results.

Mary Jensen, chairwoman of the FDA neurological devices panel, gave a statement to the publication Medical Design & Outsourcing: “The thing that worries me is that the public looks at this as, ‘Well the FDA didn’t approve it.’ The public really needs to look at it as the sponsor did not make their case because the sponsor had opportunity and input from the FDA all along the way,” she said. “There were things that the FDA recommended they do and they decided not to, and that’s completely on them.”

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