Alzheimer’s Clinical Trial Begins with Pioneering Medical Device

New medical technology is being utilized in a just-started clinical trial in patients with Alzheimer’s Disease. The trial involves treatment with a wearable head device that provides transcranial electromagnetic treatment (TEMT) to the entire brain. Banner Sun Health Research Institute and Banner Alzheimer’s Institute, both located in Phoenix, are performing this first-of-its-kind clinical trial. 
 
The 2-month Phase I clinical trial is based upon strong pre-clinical data by the study’s sponsor, NeuroEM Therapeutics Inc., showing the ability of the company’s patented electromagnetic technology to prevent and reverse memory loss in Alzheimer’s mice.
 
Several mechanisms not provided by any drug currently in Alzheimer’s clinical trials seem to be providing these cognitive benefits. First, TEMT breaks down the small protein aggregates (amyloid oligomers) inside brain cells that are now thought to initiate Alzheimer’s development in the brain. And secondly, TEMT dramatically increases the very low energy production of Alzheimer’s-diseased brain cells by enhancing their mitochondrial function—mitochondrial dysfunction is an early and critical event in the development of Alzheimer’s Disease.
 
Aside from the pioneering technology being employed, the clinical trial is unique in that Alzheimer’s patients will be receiving their treatments in-home, as administered by their family caregiver. The NeuroEM 1000 head device, worn twice daily for one-hour treatments, allows complete mobility of the patient for doing in-home activities. Therefore, the patient does not need to be taken to a hospital or clinic in order to receive their daily brain treatments.
 
Over the past 15 years, attempts to slow or reverse the debilitating memory loss of Alzheimer’s Disease with drugs have been unsuccessful. Over 100 drugs have failed in Alzheimer’s clinical trials so far. Thus, neuromodulatory (non-pharmacologic) interventions to the disease are being clinical investigated.
 
TEMT technology is very different from other neuromodulatory approaches against Alzheimer’s Disease, such as transcranial magnetic stimulation (tMS) and deep brain stimulation (DBS). tMS uses magnetic waves that stimulate brain cells only in the brain’s outer cerebral cortex, while DBS can only directly stimulate small areas of the Alzheimer’s brain. For both approaches, “diseased” brain cells are being stimulated without addressing their pathologic condition.
 
By contrast, TEMT involves interdigitated electric and magnetic waves that easily penetrate the entire human brain to hopefully provide disease intervention. This is important since Alzheimer’s Disease is global in affecting many brain areas. Moreover, the trial is ground-breaking in being the first clinical trial providing long-term electromagnetic treatment to the entire human brain.
 
Dr. Gary Arendash, president and CEO of NeuroEM Therapeutics, and his colleagues developed TEMT technology while he was research professor at the Florida Alzheimer’s Disease Research Center. “We are very pleased to have two of the country’s most notable and trusted Alzheimer’s research institutes performing this first-of-its-kind clinical trial,” said Dr. Arendash. “Although the Phase I trial is primarily to investigate safety of the TEMT head device, a number of measures have been included in the trial’s design that could provide evidence of therapeutic efficacy.”
 
Completion of the clinical trial is anticipated for this coming Spring, with public disclosure of the trial results planned to occur shortly thereafter.