TRANSCRANIAL ELECTROMAGNETIC TREATMENT (TEMT)
In 2007, NeuroEM’s Founder and Chief Executive Officer, Dr. Gary Arendash was at the University of South Florida (USF), where he began investigating the effects of TEMT on brain pathology and cognitive function in AD transgenic mice. AD is characterized by the production and aggregation of an abnormal brain protein called β-amyloid (Aβ) during aging. AD transgenic mice are genetically-engineered so that their neurons have the same human gene that produces human Aβ. Once produced, this human Aβ protein then aggregates inside and outside neurons in their brains to start the AD disease process, just as in humans.
In such AD mice, it was found that TEMT begun early in adulthood (before AD neuropathology and cognitive impairment occurs) protected AD transgenic mice from otherwise certain cognitive impairment. If TEMT was delayed until old age (when extensive neuropathology and cognitive impairment were present), TEMT reversed both the Aβ protein aggregation and the cognitive impairment of these old AD transgenic mice.
Examination of the brains from AD mice in these multiple studies clearly showed that TEMT reversed brain Aβ aggregation – a mechanism that appears central to the cognitive benefits observed in the same AD mice. This anti-Aβ aggregating effect of TEMT occurred both outside neurons (reducing the size of large Aβ deposits) and inside neurons (reducing small Aβ oligomers).
Growing evidence indicates that the small Aβ oligomers inside neurons are the primary cause of neuronal dysfunction and death in AD. In that regard, NeuroEM Therapeutics TEMT technology is unique in being the only AD therapeutic shown to prevent and reverse Aβ aggregation both inside and outside neurons. To our knowledge, no drug currently being developed has this critical ability. Importantly, no deleterious effects of daily TEMT (for up to 8 months) were evident in brain or body of treated AD mice, based on multiple histologic, neurochemical, and blood markers evaluated.
Following their initial 2010 paper, Dr. Arendash and colleagues published five additional papers that further underscore the utility of TEMT in AD transgenic mice to enhance cognitive function and reduce brain AD neuropathology. These follow-up papers have identified two additional mechanisms of action that work in concert with the anti-Aβ aggregation mechanism initially identified – namely, mitochondrial enhancement (to increase energy production in neurons) and increased neuronal activity in brain regions impacted by AD. These additional mechanisms are important because brain mitochondrial dysfunction and decreased neuronal activity occur very early in the AD process – well before memory impairment is noticed.
TEMT technology is similar in a number of ways to the electromagnetic waves generated by cell phones. Numerous studies in normal humans have shown that such exposure provides beneficial cognitive changes to the EEG, increases brain energy production, and has no deleterious effects on health over many years. In technology also similar to our TEMT, electromagnetic treatment is already an established therapeutic when given to the body (arm, torso, etc.) to treat pain, fracture repair, and wound healing. Therefore, electromagnetic treatment for human conditions has been around for years .
CURRENT DEVELOPMENTAL STATUS
NeuroEM Therapeutics’ Phase I clinical trial was approved in early 2016 by the Western Institutional Review Board (WIRB). The WIRB also designated the company’s MemoEM 1000 head device being used in that trial as a Non-Significant Risk device. This pioneering trial is now on-going at the University of South Florida’s Byrd Alzheimer’s Institute in Tampa, Florida. It is the first clinical study involving long-term administration of TEMT to the entire human brain. Completion of the trial is anticipated for Spring 2018, with public disclosure of the results shortly thereafter. The design and details of this clinical trial can be attained by going to ClinicalTrials.gov and entering the indicator number NCT 02958930 into the search window or by typing in “Alzheimer’s, electromagnetic”.
Since 2010, Dr. Gary Arendash (CEO and President) and seven collaborating laboratories have published six peer-reviewed papers in first tier scientific journals detailing the effects of TEMT on behavior, neuropathology, and physiologic processes in AD mice. These papers are listed below. Because Dr. Arendash’s 2012 and 2016 review articles summarize work from the prior papers, they can be conveniently downloaded directly from this web page.
Arendash, G.W. Review of the Evidence that Transcranial Electromagnetic Treatment (TEMT) will be Safe and Effective Against Alzheimer’s Disease. Journal of Alzheimer’s Disease, in press. EMF Review in JAD
Arendash, G.W. Transcranial Electromagnetic treatment (TEMT) for Alzheimer’s Disease: Why it has the potential to trump Alzheimer’s drug development. Journal of Alzheimer’s Disease 32:243-266, 2012. EMF Review in JAD.
Arendash G.W., Mori, T., Dorsey, M., Gonzalez, R., Tajiri, N., and C. Borlongan. Long-Term 918 MHz Electromagnetic Field Treatment to Very Old Alzheimer’s Mice Reverses β-Amyloid Deposition, Modifies Regional Cerebral Blood Flow, & Provides Selected Cognitive Enhancement without Brain Hyperthermia. PLoS ONE http://dx.plos.org/10.1371/journal.pone.0035751, 2012.
Mori, T. and G.W. Arendash. Electromagnetic field treatment enhances neuronal activity: Linkage to cognitive benefit and therapeutic implications for Alzheimer’s Disease. Journal of Alzheimer’s Disease and Parkinsonism Vol. 1:102 http://dx.doi.org/10.4172/2161-0460.1000102, 2011.
Dragicevic, N., Bradshaw, P.C., Mamcarz, M., Lin, X., Wang, L., Cao, C., and G.W. Arendash. Long-term electromagnetic field treatment enhances brain mitochondrial function of both Alzheimer’s transgenic mice and normal mice: A mechanism for electromagnetic field-induced cognitive benefit? Neuroscience 185: 135-149, 2011.
Arendash., G.W., Sanchez-Ramos. J., Mori, T., Mamcarz, M., Lin, X., Runfeldt, M., Wang, L., Zhang, G., Sava, V., Jun Tan, J., and C. Cao Electromagnetic Field Treatment Protects Against and Reverses Cognitive Impairment in Alzheimer’s Mice. Journal of Alzheimer’s Disease 19: 191-210, 2010.
NeuroEM Therapeutics’ Phase I clinical trial is being performed at the University of South Florida’s Byrd Alzhiemer’s Institute in Tampa, FL. The Byrd Institute is the largest free-standing Alzheimer’s Institute in the world and has a large staff of experienced Alzheimer’s clinicians/researchers. The Principle Investigator for this first-of-its-kind clinical trial is Dr. Amanda Smith, Director of Clinical Trials at the Institute. She is working with Jill Smith, MA, CCRC, who is coordinating the Phase I trial. NeuroEM Therapeutics is most pleased to have the Byrd Institute doing this trial, particularly since its clinicians are committed to exploring promising approaches against Alzheimer’s Disease beyond standard Big Pharma-sponsored drug trials.
Product Development Timeline
NeuroEM Therapeutics has a very aggressive clinic-to-market timeline of 4 years. More information regarding this timeline can be requested by contacting the company.
In 2013, NeuroEM Therapeutics signed an exclusive worldwide license agreement with the University of South Florida (USF) for use of their recently awarded U.S. patent (US 9,238,149 B2) and the technology developed by Gary Arendash, Ph.D while he was at USF. The major claims of this patent are that TEMT can prevent and reverse the cognitive dysfunction in Alzheimer’s Disease and other neurologic conditions involving Aβ aggregation. A follow-up CIP was filed in 2015 further expanding on these claims.
In addition, NeuroEM Therapeutics submitted a non-provisional patent application (US 2014/0257017 A1), published in 2014, that describes a self-contained head device for administration of electromagnetic treatment against a spectrum of neurologic conditions.
In 2016, NeuroEM Therapeutics entered into an exclusive license agreement with Remarkable Technologies (Connecticut) involving their patent (US 9,238,149 B2) for a parallel application of electromagnetic technology into a head device. As the TEMT head devices are further refined, extensive technical data is being collected for the filing of additional non-provisional patents, with the objective of building a substantial patent portfolio around the technology and devices.