An open clinical trial that worked with eight people with Alzheimer’s disease concluded that a new wearable device that emits electromagnetic pulses was able to significantly improve memory loss in seven of these participants within 2 months.
Alzheimer’s disease affects millions of people around the world, but there is still no cure for this progressive neurodegenerative condition.
Now, a team of researchers affiliated with NeuroEM Therapeutics, a Phoenix-based medical device company, has developed a wearable device that, according to their latest experiment, can significantly reduce memory loss in Alzheimer’s. by breaking down the toxic protein formed in the brain.
The device is shaped like a cap and emits electromagnetic waves at a frequency that preclinical studies in mice have shown can help reverse memory loss.
“These results provide preliminary evidence that the administration [of transcranial electromagnetic therapy] that we evaluated in this small study may have the ability to improve cognitive performance in patients with mild to moderate disease,” explains Amanda Smith, co-author of the work, journal of Alzheimer’s Disease published the study.
‘Highly significant improvement’ at 2 months
For the trial, the researchers worked with eight participants with mild to moderate Alzheimer’s disease and their caregivers, who were instructed on how to use the therapeutic device at home. Participants received the treatment twice a day for two months, and each session lasted 1 hour.
After two months, none of the participants had experienced any side effects. Brain scans performed by the experts at the end of the study showed that the eight people had not developed brain tumors or bleeding as a result of using the device.
To assess whether the treatment had helped the participants, the researchers used the Alzheimer’s Disease Assessment Scale Cognitive Subscale Test (ADAS-cog), the most widely recognized method for assessing cognitive function.
The team found that seven of the eight participants saw an increase of more than 4 points in cognitive performance on the ADAS-cog scale after 2 months. This, the authors explain, is as if the participants’ cognitive function had “rejuvenated” for a year.
“We were especially surprised that this highly significant improvement in ADAS-cog was sustained even 2 weeks after treatment was completed,” says Gary Arendash, CEO of NeuroEM Therapeutics. “The most likely explanation for the continued benefit after discontinuation of treatment is that the Alzheimer’s disease process itself was being affected.”
The researchers also collected blood and cerebrospinal fluid samples from the participants, both at the start and end of the clinical trial.
Upon analyzing them, they found that the intervention appeared to have led to the breakdown of beta-amyloid plaques and tau tangles , which are associated with progressive decline in cognitive function in Alzheimer’s.
Furthermore, the MRIs also suggested that after the two-month treatment period , the participants had better communication between brain cells present in the cingulate cortex, which plays a key role in cognitive function, including decision-making. .
All participants decided to keep the devices they obtained as part of the clinical trial.
The next step
The researchers do not plan to stop at this small clinical trial. In the future, they have offered the current trial participants the opportunity to participate in a much larger clinical trial, which they are already organizing and have all accepted the offer. The new trial will last about 17 months, on average, and will include 150 participants with a diagnosis of mild to moderate Alzheimer’s disease.
The company hopes to be able to obtain Food and Drug Administration (FDA) approval for its technology in the next two years and make the device available to the public by 2021.
Referencia: A Clinical Trial of Transcranial Electromagnetic Treatment in Alzheimer’s Disease: Cognitive Enhancement and Associated Changes in Cerebrospinal Fluid, Blood, and Brain Imaging : Arendash, Garya; | Cao, Chuanhaib | Abulaban, Haithamc | Baranowski, Robd | Wisniewski, Garye | Becerra, Linoe | Andel, Rossf; | Lin, Xiaoyangb | Zhang, Xiaolinb | Wittwer, Davidh | Moulton, Jayi | Arrington, Johnj | Smith, Amanda / Journal of Alzheimer’s Disease, vol. 71, no. 1, pp. 57-82, 2019 Published: 03 September 2019 DOI: 10.3233/JAD-190367
