Promising new device for Alzheimer’s treatment used in small pilot study at USF

Hillsborough County

TAMPA, Fla. (WFLA) – A wearable device developed by an Arizona company with ties to USF Health’s Byrd Alzheimer’s Institute recently underwent a very small, but successful, pilot study.

NeuroEM Therapeutics created a helmet they call the “MemorEM” head device. It utilizes Transcranial Electromagnetic Treatment – or TEMT.

The electromagnetic waves used in TEMT appear to reverse memory impairment in Alzheimer’s patients.

The company is headed by a former USF Health scientist, Dr. Gary Arendash. He worked on the technology with mice while in Tampa and found it to be successful.

Now that it can be tested on humans, the small study of eight people, with no placebo group, was conducted at the Byrd Alzheimer’s Institute.

(Source: NeuroEM Therapeutics, Inc.)

Dr. Arendash contacted Dr. Amanda Smith, Director of Clinical Research at the Byrd Alzheimer’s Institute, last year.

“Anytime we’re testing out new treatments for illnesses, there has to be a pilot study that shows that it’s safe and effective before you move onto bigger studies,” she said.

Dr. Smith explained that the patients wore the soft helmet for about an hour twice a day and could go about their business around their homes while using it.

She said the results in the eight patients were “interesting and positive” in a field where they have had many failures.

The device seemed to break down an abnormal protein called amyloid in a patient’s brain.

According to the Mayo Clinic, amyloid is produced in bone marrow and can be deposited in any tissue or organ. Patients with Alzheimer’s disease have a build-up of amyloid plaques in their brains.

Dr. Smith said that a “large group” in the scientific community believes that the protein is the real target for treating Alzheimer’s disease.

“So when we saw that not only the test scores were improving in some of the subjects, but their amyloid markers in their blood and spinal fluid were also changing. That indicates that the device is actually doing something,” she explained.

Dr. Smith said several patients’ test scores went up in certain aspects of memory and thinking, but not necessarily across the board. Other patients’ scores stayed the same.

“There are – and we have been a part of – many, many trials where there was not any movement in the markers, where there was very little, if any difference as far as cognitive testing before or after the treatment,” she said. “So in this study, even though it was very tiny, it’s encouraging to see both cognitive and biomarker results going in the same direction. The right direction.”

While Transcranial Electromagnetic Treatment may sound like a treatment already approved by the FDA for depression, the doctor said the dose of magnetic field in depression treatment is “significantly lower” than what the device for TEMT uses.

Transcranial Magnetic Stimulation for depression also focuses on a very specific area, whereas the treatment for Alzheimer’s disease features numerous sensors around the helmet.

Dr. Smith is excited but cautiously optimistic about the future of Alzheimer’s disease treatment with the results of this study, and recent news about a drug to manage the disease being one step closer to getting approval from the federal government.

Those at the Byrd Alzheimer’s Institute were involved in the trial for the drug previously but shut it down earlier this year.

“I’m not holding my breath but I am excited that that news came out and that people finally have hope for some new treatment that actually targets the amyloid, the underlying disease process, rather than just treating symptoms like the drugs we have on the market now,” Dr. Smith said.

As for the wearable device to reverse memory loss due to Alzheimer’s, the general public will have to be patient.

“We’ve had people kind of knocking down the door with interest in this, particularly because it’s not a pill, it’s not something that’s going to interact with other drugs and things and it’s not something that we’re able to offer people right now,” Dr. Smith explained.

NeuroEM is preparing for a pivotal clinical trial of the TEMT device around the country but the locations have not yet been announced.

On its website, the company says it anticipates the device could be available for commercialization by late 2021 or early 2022.

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