- Researchers are examining whether electromagnetic fields can help treat Alzheimer’s disease.
- But experts stress that we’re in the extremely early days of this research, and no one knows yet whether this is an effective treatment.
- Alzheimer’s disease is among the top 10 causes of death in the United States, but it has no cure or effective treatment.
- In recent decades, many potential medications for Alzheimer’s disease have appeared successful in early trials, only to fail in phase III testing.
An Alzheimer’s treatment that could actually stop the disease and even reverse damage to memory and cognitive function would be the holy grail.
Over the years there have been many potential therapies for Alzheimer’s disease that seemed to have great promise. And then once in trials, the therapies don’t actually help stop the disease.
And it’s been making headlines as a breakthrough.
But experts who have seen many treatments appear to be a “breakthrough” in early testing, only to fail during phase III trials, say people should be cautious and wait for more information before getting their hopes up about an effective treatment.
In new research, published in the Journal of Alzheimer’s Disease, Arendash and his team lay out compelling, if limited, findings for the use of transcranial electromagnetic treatment (TEMT) to treat Alzheimer’s disease.
TEMT is part of an umbrella of experimental, nonpharmacological treatments for Alzheimer’s disease. Arendash believes the technology has the potential to move the field forward, where traditional medication treatments for the disease have failed.
“There have been about 150 drugs that have failed in Alzheimer’s clinical trials so far in 15 years. We believe the reason for that is that, first of all, drugs have a hard time getting into the brain and then into the neurons,” Arendash said.
“Electromagnetic fields do that with no problem,” he said. “They penetrate from the surface of the skull deep into the brain, no problem whatsoever.”
The goal: dislodge or disaggregate two toxic proteins, Aβ and p-tau oligomers, inside the neurons of the brain that are known to be associated with the development of Alzheimer’s disease.
Their pilot study for the device, known as the MemorEM, which looks something like a swimmer’s cap attached to an electronic control device that’s worn around the arm, appears to hold some promise.
The small study included eight people aged 63 to 82 who had mild to moderate Alzheimer’s disease. All of them underwent baseline testing, including brain scans, blood work, samples of cerebrospinal fluid, and cognitive and memory testing.
Participants used the TEMT device twice a day, 1 hour per session, for 2 months. After the 2-month period, researchers conducted further tests to check against their baseline scores.
The trial appeared safe, with no reported behavioral changes or adverse physiological effects.
Additionally, 7 out of 8 participants had robust improvement on cognition and memory.
“At the end of that period of time, their memory performance had actually improved, not stabilized but improved, back to the better memory that they had a year earlier. So, it’s like going back in time as far as memory goes,” Arendash said.
The researchers also looked at biomarkers at the end of the test period for confirmation.
They found that at the end of the 2 months there was an increase in the presence of amyloid beta in cerebrospinal fluid and tau protein in the blood.
Researchers claim this phenomenon is indicative of TEMT-induced breakdown of those harmful proteins.
That’s what makes TEMT so tantalizing. But it’s another reason why experts stress early success doesn’t mean it will be an effective treatment.
Despite the trial’s promise, experts in the field say it’s far too early in the technology’s life cycle to hail it as the next big development for Alzheimer’s disease treatment.
“I think that there’s a lot more research that is needed,” said Rebecca Edelmayer, PhD, director of scientific engagement at the Alzheimer’s Association.
Edelmayer says using these devices isn’t novel for brain research.
“But they are a little bit newer in terms of their methodology and approach towards Alzheimer’s disease,” she said. “So, I wouldn’t say it’s really understood well whether or not they will potentially have any meaningful benefit for people living with Alzheimer’s disease and for all dementias.”
Dr. Alan Manevitz, a clinical psychiatrist and expert in transcranial magnetic stimulation (TMS) at Lenox Hill Hospital and medical director of Sutton Place TMS, calls the study “well designed,” but he also has his own reservations.
Among those were the “open-label,” nonrandomized nature of the trial and its length. There also remain numerous unresolved questions regarding what happens when treatment is stopped.
“What happens clinically to improvement of cognition after treatment is stopped?” Manevitz asked. “Do patients get more improvement if TEMT is given over a longer time in this brain-degenerative disease? And what happens to the toxic conglomeration of plaques and tangles in these situations?”
Funding for the study also came from the University of South Florida, which is disclosed in the paper as having a financial interest in NeuroEM Therapeutics.
Arendash hopes to take on many of the criticisms to further prove the efficacy of TEMT on Alzheimer’s in their next clinical trial.
A subsequent “pivotal” trial would be placebo-controlled and include about 150 patients at multiple sites throughout the United States.
A lot of things have to go right for TEMT to reach approval status by the Food and Drug Administration (FDA), but the development pipeline would be significantly shorter than for a new Alzheimer’s medication.
If that trial is successful, a TEMT device for Alzheimer’s disease could be on the market in 2 to 3 years.
“If that pivotal trial is successful, even partially to the effect that we’ve gotten already, we would be hopeful the FDA would approve TEMT as the first therapeutic against Alzheimer’s in 15 years,” Arendash said.
Until a larger trial is successful, however, there are no guarantees.
Edelmayer says the early research is encouraging, and that more research is needed to help people with Alzheimer’s disease.
“People are starting to think outside the box and approach Alzheimer’s disease and all dementias from all angles, but I think we need more research and much more controlled and randomized clinical trials to help us better understand whether or not these types of therapies could be beneficial,” Edelmayer said.