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Trial to Test Radio Waves to Treat Alzheimer’s

Nerve cells illustration

(commonfund.nih.gov)

6 December 2016. A clinical trial is inviting individuals with Alzheimer’s disease to test a device that its designers claim can reverse cognitive impairment resulting from Alzheimer’s disease. The study is conducted by NeuroEM Therapeutics Inc., the Phoenix-based developer of the transcranial electromagnetic treatment device being tested.

Alzheimer’s disease is a progressive neurodegenerative disease affecting growing numbers of older people worldwide. People with Alzheimer’s disease often have deposits of abnormal substances in spaces between brain cells, known as amyloid-beta peptides, as well as misfolded tangles of proteins inside brain cells known as tau. The Alzheimer’s Association says some 5.4 million individuals in the U.S. have the disorder, of which 5.2 million are age 65 or older. By 2050 that number is expected to increase to 13.8 million.

NeuroEM Therapeutics was founded in 2013 by Gary Arendash, based on research he conducted while on the faculty at University of South Florida. There, he began investigating the ability of electromagnetic waves to prevent and in some cases reverse the cognitive decline in genetically-engineered mice induced with human Alzheimer’s disease. Arendash is now NeuroEM Therapeutics’ full-time president and CEO.

The company’s transcranial electromagnetic treatments were shown in preclinical studies to prevent cognitive impairment of younger mice, before amyloid-beta peptides began accumulating into plaques. A related study with older genetically-engineered mice showed the transcranial electromagnetic treatments reversed accumulations of amyloid-beta peptides, as well as cognitive impairment displayed by the animals.

Subsequent studies showed electromagnetic treatments could prevent and reverse proteins from penetrating and accumulating inside neurons, causing further damage, as well as enhance the mitochondrial, or cellular energy components in neurons, and increase neural activity in the brain. The preclinical studies showed no harmful effects of the treatments on the brain functions, immune systems, or DNA of the test mice.

The clinical trial is recruiting 14 participants with mild to moderate Alzheimer’s disease to evaluate the safety of the company’s device, known as the MemorEM 1000. The MemorEM 1000 is worn on the head for up to 2 hours a day for 60 days, emitting electromagnetic waves at 900 MHz, similar to cell phones. The trial is being conducted at the Banner Sun Health Research Institute and Banner Alzheimer’s Institute in or near Phoenix.

The study is looking particularly for changes in participants’ scores on the Alzheimer’s Disease Assessment Scale-cognitive subscale, or ADAS-cog, a standard assessment measure of cognitive impairment associated with Alzheimer’s. The researchers will also conduct PET scans and functional MRI tests to determine changes in brain functions and connectivity, as well as conventional MRI scans to identify any brain hemorrhages or tumors. In addition, the team will test the blood and cerebrospinal fluid of participants for amyloid-beta and tau proteins, and indicators of adverse effects on the immune system and oxidative stress.

NeuroEM Therapeutics expects to complete the clinical trial in the spring of 2017 and report the results soon thereafter.

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