University of South Florida Health’s Byrd Alzheimer’s Institute partnered with device developer NeuroEM Therapeutics to complete an open-label clinical trial working with 8 participants with Alzheimer’s disease. The study sponsor and team declared that a novel wearable device that emits electromagnetic impulses was able to significantly improve memory loss in seven of these participants within two months evidencing notable results.

The Study

The study sponsor sought to determine the safety and efficacy of Transcranial Electromagnetic Treatment (TEMT) in patients with mild to moderate Alzheimer’s disease. Throughout the 2-month treatment period, patients were evaluated for cognitive performance, brain energy utilization, functional brain imaging, and blood/cerebrospinal fluid (CSF) markers for Alzheimer’s disease. All the patients were to receive TEMT and each patient’s baseline measurements served as their control for any treatment effects.

The Background

Researchers affiliated with NeuroEM Therapeutics, based in Phoenix, Arizona, have developed a wearable device that according to their recent open-label clinical trial, can significantly reduce memory loss in Alzheimer’s by disaggregating toxic protein formed in the brain. Paul Field of Medical News Today reports that the NeuroEM Therapeutics investigational product while investigated in preclinical studies on mice emitted electromagnetic waves in a frequency that can help reverse memory loss. The results of this interesting study were reported in the Journal of Alzheimer’s Disease

Investigator Comment

Dr. Amanda Smith, director of clinical research, University of South Florida Health’s Byrd Alzheimer’s Institute in Tampa, Florida noted: “Despite significant efforts for nearly 20 years, stopping or reversing memory impairment in people with Alzheimer’s disease has eluded researchers.”

The Study Results

The team worked with 8 participants with mild to moderate Alzheimer’s disease and their caretakers, who received instructions for how to use the device at home. The treatment was administered twice a day, for one hour sessions, for 2 months. At the end of the month, two none of the participants experienced any side effects—there were no tumors or brain bleeding as a consequence of this device.

The investigators utilized the Alzheimer’s Disease Assessment Scale—Cognitive Subscale test (ADAS-cog), which is reported by Medical News Today’s Ms. Field to be the most common cognitive function assessment method.

The results were promising; in fact, seven of the eight participants experienced an increase of over 4 points in cognitive performance on the ADAS-cog scale after 2 months. It is as if a cognitive function has been rejuvenated by a year.

Other Interesting Results

Upon collecting blood and cerebrospinal fluid samples from participants at both baseline and at study end they found that the intervention possibly led to the disaggregation of beta-amyloid plaques and tau tangles—elements associated with progressive cognitive function impairment in Alzheimer’s.

MRI scales also led investigators to conclude that participants had better communication between brain cells present in the cingulate cortex after the 2-month treatment. The cingulate cortex is involved with a cognitive function such as decision making.

All the participants wanted to keep the devices after the trial—they wanted to keep using them.

Next Steps: Additional Trials

As a result of this initial study, the investigators will keep conducting studies. They are offering trial participants the chance to take part in much larger clinical trials. All the participants have opted-in. The new study will include about 150 participants and last approximately 17 months.

NeuroEM Therapeutics

The device company, NeuroEM Therapeutics strives for FDA acceptance for the device by 2021. Based in Phoenix, Arizona the company is committed to testing and marketing Transcranial Electromagnetic Treatment (TEMT) as effective prevention and treatment for Alzheimer’s disease & other neurodegenerative diseases. They believe that their non-invasive bioengineering technology shows tremendous promise to prevent, halt and reverse the memory impairment of Alzheimer’s disease.

The founder, Dr. Gary Arendash was with the University of South Florida (USF) in 2008 when he began investigating TEMT on brain pathology and cognitive function in AD transgenic mice with his USF colleague Chuanhai Cao. NeuroEM Therapeutics is privately held and doesn’t disclose any financial information. TrialSite News did a review and believes they are pre-revenue and employ under 10 employees.

Lead Research/Investigator

Dr. Amanda Smith, Director of Clinical Research, University of South Florida Health’s Byrd Alzheimer’s Institute in Tampa

Call to Action: Interested in monitoring a new approach to addressing memory loss associated with Alzheimer’s disease? Monitor the ongoing TEMT studies sponsored by NeuroEM Therapeutics—led by Dr. Amanda Smith with USF. Also, sign up for the TrialSite Newsletter for more information.

Source: Medical News Today

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