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Trial Shows Radio Waves Safe for Alzheimer’s Therapy

brain stimulationgraphic

(Media News, Flickr)

18 Sept. 2019. Results from a small clinical trial show a treatment for Alzheimer’s disease using radio waves is safe and offers early evidence it can reverse memory loss. Findings from the trial conducted by NeuroEM Therapeutics Inc. in Phoenix appear in the 3 September issue of the Journal of Alzheimer’s Disease.

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 5.8 million individuals in the U.S. have the disorder, and by 2050 that number is expected to increase to 14 million.

The clinical trial tested the NeuroEM system called Transcranial Electromagnetic Treatment, or TEMT, mainly for safety with Alzheimer’s patients, but also for signs of efficacy. The device uses eight radio wave antennas woven into a cap worn over the patient’s head, with the antennas emitting radio wave pulses in frequencies similar to cell phones. The individual wears the cap for two sessions of one hour each during the day, separated by at least a seven-hour interval. The head cap is wired to battery-powered control panel worn on the upper arm.

As reported by Science & Enterprise in December 2016, preclinical studies show transcranial treatments can prevent cognitive impairment of younger mice, before amyloid-beta peptides began accumulating into plaques. With older genetically-engineered mice, the treatments reversed accumulations of amyloid-beta peptides, as well as cognitive impairment displayed by the animals. Further preclinical studies indicate the treatments can 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.

The early-stage clinical trial recruited eight participants with mild to moderate Alzheimer’s disease at University of South Florida’s Byrd Alzheimer’s Center in Tampa. Participants wore the TEMT device for twice-daily sessions at home for 60 days, with the study team conducting a follow-up evaluation two weeks after the last treatment.

The researchers looked primarily for signs of adverse effects from the treatments. The team also assessed participants with a standard Alzheimer’s Disease Assessment Scale–Cognitive Subscale, or ADAS-Cog, that measures the level of cognitive dysfunction in Alzheimer’s disease and the Rey Auditory Verbal Learning Test measuring short-term auditory-verbal memory and related functions. In addition, the team measured changes in brain and central nervous system chemistry indicating changes in toxic protein levels.

The study team found no evidence of physiological or behavioral harm from the treatments, including signs of bleeding in the brain or evidence of tumor formation from MRI scans. The findings show seven of the eight participants recorded higher scores of memory retention on the ADAS-Cog scale at the end of the 60-day treatments compared to before the treatments that continued in the 14-day follow-up test. The eighth participant showing decreases in memory function typical of people with Alzheimer’s disease.

Scores on forgetfulness measures in the Rey Auditory Verbal Learning Test from before to after treatments also declined, but other cognitive indicators in the small sample were not large enough for statistical reliability. In addition, tests of cerebrospinal fluid, blood, and glucose in the brain from PET scans show at least modest improvement in indicators of amyloid-beta and tau proteins, as well as brain connectivity, which correlate with participants’ ADAS-Cog scores.

Amanda Smith, medical director of the Byrd Institute at USF and a co-author of the paper, says in a NeuroEM statement, “These results provide preliminary evidence that TEMT administration we assessed in this small AD study may have the capacity to enhance cognitive performance in patients with mild to moderate disease.”

NeuroEM is extending the study to document effects over an average of 17 months following treatment. And the company is planning a larger-scale clinical study recruiting 150 patients to test the TEMT treatments.

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