NeuroEM Therapeutics‘s MemorEMTM — a head-worn device that uses electromagnetic waves — has shown promising results in a preliminary clinical trial of people with mild-to-moderate Alzheimer’s disease. Seven of eight participants demonstrated improved memory after two months of treatment.
The results, “A Clinical Trial of Transcranial Electromagnetic Treatment in Alzheimer’s Disease: Cognitive Enhancement and Associated Changes in Cerebrospinal Fluid, Blood, and Brain Imaging,” were published in the Journal of Alzheimer’s Disease.
MemorEMTM is an investigational technology that uses Transcranial Electromagnetic Treatment (TEMT). It is a cap that sends specialized electromagnetic waves through the brain. It is designed to be worn during daily activities, and for easy placement by a caregiver.
Previous studies in mice suggested that TEMT could help break up clumps of the proteins amyloid-beta and tau in the brain. Such clumps are thought to be major drivers of Alzheimer’s pathology, but finding therapies that can get all the way into brain cells and then disassociate the clumps has been a major challenge. TEMT may be able to circumvent that.
In this first in-human study (NCT02958930), which was funded by NeuroEM Therapeutics, eight participants (two men, six women, average age 71 years) were treated with TEMT via MemorEMTM for two months. Sessions were administered for an hour twice daily; in total, each participant received about 120 hour-long sessions.
The participants’ caregivers were asked to keep diaries detailing any adverse side effects or unusual behaviors. The treatment did not cause recurrent changes in mood or behavior in any of the participants, and no serious adverse side effects were reported. Additionally, brain scans showed no evidence of brain tumors or bleeding in the brain.
Participants’ cognitive function was assessed before treatment, after the two months of treatment, and again two weeks after completing the study using the Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-cog), a standard test for measuring cognitive function in Alzheimer’s.
Seven of the eight participants had an improvement in ADAS-cog score after two months of treatment. On average, these responders’ scores improved by 4.3 points. Typically, people with Alzheimer’s demonstrate a decrease in ADAS-cog scores of about four points per year, so this is a sizable improvement. It should be noted that this was an average change; only three participants’ individual scores improved by four points or more.
Two weeks after stopping treatment, this average increase was maintained (though, again, individual changes varied). Gary Arendash, PhD, CEO of NeuroEM Therapeutics and a co-author of the study, explained in a press release: “The most likely explanation for continued benefit after cessation of treatment is that the Alzheimer’s Disease process itself was being affected.”
The one non-responder participant showed a change in ADAS-cog score comparable to what has been observed in previous studies of untreated people with Alzheimer’s.
In addition to changes in cognition, the researchers noted changes in levels of amyloid-beta- and tau-related molecules in the patients’ blood and cerebrospinal fluid (the fluid surrounding the brain and spinal cord). These changes were consistent with what would be expected if clumps of these proteins in the brain were being broken up, suggesting that TEMT functions as expected.
Furthermore, MRI scans indicated that all participants had increased connectivity between neurons in a part of the brain called the cingulate/cingulum after the two-month treatment. The implications of this observation are not entirely clear, but this brain region is known to be involved in memory.
“These results provide preliminary evidence that TEMT administration we assessed in this small AD study may have the capacity to enhance cognitive performance in patients with mild to moderate disease,” said Amanda Smith, MD, director of clinical research at the University of South Florida Health, Byrd Alzheimer’s Institute, where the study was done; Smith also is a co-author of the study.
Arednash added “Perhaps the best indication that the two months of treatment was having a clinically-important effect on the AD patients in this study is that none of the patients wanted to return their head device … after the study was completed.”
Participants were allowed to enroll in an ongoing four-month extension study (NCT03927040) to further evaluate MemorEMTM’s effect on cognition.
NeuroEm Therapeutics said it is planning a larger trial of TEMT in people with mild-to-moderate Alzheimer’s, which is expected to begin recruitment toward the end of this year. If safety and cognitive benefits continued to be verified, the company plans to ask the U.S. Food and Drug Administration (FDA) for approval of the MemorEM device.
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