Millions of people around the world that suffer from Alzheimer’s Disease (AD) are without any encouraging hope that a remedy will arrive. Once in a while, you hear about something that maybe could result in something that might be able to help. This time, there is hopeful news about a treatment that has shown itself to actually be effective. NeuroEM Therapeutics recently announced findings from an open-label clinical trial conducted with a wearable head device for in-home treatment. The results were an impressive reversal of cognitive impairment in AD patients after just two months of treatment.
The non-invasive procedure uses brain stimulation in the form of electromagnetic waves – known as Transcranial Electromagnetic Treatment (TEMT) – to increase functional connectivity within the cingulate cortex. TEMT is able to slow the progression of AD by penetrating the brain and breaking up amyloid-beta and tau deposits (toxic proteins that have been linked to causing AD.) This ability of TEMT to disaggregate these toxic proteins is the golden ticket to reversing cognitive loss in patients. It is what makes the device such a promising treatment in enhancing memory and cognitive function in those with AD. The study has been published in the Journal of Alzheimer’s Disease.
The Device
- Within the head cap of the device are multiple, highly-specialized emitters that are activated sequentially, with treatments easily administered at home by the patient’s caregiver (spouse or family member).
- The device is very easy to use and doesn’t require the user to stop everything to sit with the cap on during treatment. A user can go about their day normally with complete mobility to perform nearly all household activities during treatments.
The Trial (Open-label Study)
- It was a one-off testing that involved only 8 patients 63 years of age and older with mild to moderate AD. They enrolled at the University of South Florida Health/Byrd Alzheimer’s Institute to participate.
- The study’s focus was to evaluate the safety and initial efficacy of Transcranial Electromagnetic Treatment (TEMT).
- Treatment was administered using the MemorEM device in the patient’s home by a caregiver.
- Patients received TEMT for one-hour periods twice daily for two months. – an overall 120 treatments were administered in-home.
The Results
- Although limitations of this study include the small number of subjects, not having a control group, and being of relatively short treatment duration, the cognitive benefits observed were “clinically important/meaningful at the highest levels.”
- Not only were there observed cognitive enhancements, but there were also beneficial changes in AD markers in blood and CSF, as well as the enhancement in brain MRI imaging.
- There were no side effects at all in any of the eight patients demonstrating that TEMT is safe. None of the eight patients in the study exhibited any deleterious side effects on behavior or physiologic measures, as recorded by caregivers in daily diaries. In addition, post-treatment brain scans revealed no visible induction of tumors or brain bleedings called microhemorrhages.
- Seven of the participants showed enhanced cognitive performance, as measured by their ADAS-cog score, which is the benchmark for testing AD therapeutics.
But the best indicator of its effectiveness lies in the fact that nobody wanted to return the headset. Dr. Gary Arendash, CEO of NeuroEM Therapeutics, said:
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 to the University of South Florida/Byrd Alzheimer’s Institute after the study was completed.
One patient even proclaimed:
I’ve come back.
Using the benchmark ADAS-cog task to assess a variety of cognitive measures, the seven participants that saw an improvement collectively responded to treatment with a 4+ point increase in cognitive performance by the end of the 2-month treatment period. Normally, AD patients show a 4+ point decline in ADAS-cog performance over a given one year period – which means that the 4+ point improvement provided by TEMT was as if the treated patients had gone back in time to their better cognitive performance from the year prior.
Dr. Arendash said:
We were particularly surprised that this highly significant improvement in the ADAS-cog was maintained even two weeks after treatment was completed. The most likely explanation for continued benefit after cessation of treatment is that the Alzheimer’s Disease process itself was being affected.
TEMT has great potential to be an entirely new therapeutic intervention against AD. The researchers believe their NeuroEM’s bioengineering technology may be succeeding where drug therapy against AD has so far failed.
NeuroEM Therapeutics is currently planning another clinical trial, this time with approximately 150 mild/moderate AD subjects to be treated with the company’s MemorEMTM device. If all goes well they will ask the FDA for approval of the MemorEM device for treatment of AD. Meanwhile, since the participants from the first trial were so enthusiastic, they have allowed them to continue their treatment. Those patients are now part of an on-going extension study averaging 17 months between the initial study start and extension study finish. More information about it is available on NeuroEM’s website.
