Background

MemorEM™ is a patented, noninvasive technology that delivers ultrahigh radio frequency electromagnetic waves to the brain. The device consists of a cap with eight embedded transmitters and a control box worn in an arm strap. It produces electromagnetic waves in the 1,000 MHz range that penetrate the skull and underlying brain areas. The exposure is similar to that associated with cellphone use. Patients wear the device at home for two hours a day. They experience no sound or sensation associated with it, and can move around freely.

The primary mechanism of action is claimed to be disaggregation of toxic Aβ and tau oligomers. In preclinical work, two to eight months of exposure to electromagnetic waves at 918 MHz for two hours daily increased performance on several cognitive tests in AβPPsw transgenic Alzheimer’s mice, increased memory in 24- to 27-month-old transgenic mice, and reduced Aβ deposition (Arendash et al., 2010; Arendash et al., 2012). The treatment also improved cognitive performance in normal mice. It reduced regional blood flow in cerebral cortex. In AD mice and in vitro, TEMT disrupted Aβ oligomers, and increased mitochondrial function and neuronal activity (Dragicevic et al., 2011; also see Arendash 2012 for review).

This work was carried out by one group. Independent groups have reported benefits of radiofrequency exposure on cognition and pathology in AD mouse models (e.g. Babaceur et al., 2013; Son et al., 2018), and in people (Guerriero et al., 2015), albeit using different stimulation parameters.

Data from animal and human studies indicates that exposure to electromagnetic waves at comparable frequencies and power levels, e.g., by cellphone use, is safe, and does not raise the risk of brain cancer (see Arendash 2016).

Findings

In 2017-2018, NeuroEM ran a pilot open-label trial in eight patients with mild to moderate AD, who received twice-daily hour-long sessions of TEMT at home for two months, administered by a caregiver. The device delivers 918 MHz frequency at a power level of approximately 1 W/kg, and a pulse repetition rate of 217 Hz. The trial ran at the Byrd Alzheimer’s Institute in Tampa, Florida, where investigators measured outcomes including cognition, brain imaging, blood and CSF biomarkers, and safety. According to published results, after treatment, seven of eight patients improved their ADAS-Cog scores by an average of 4 points, and all improved on the Rey Auditory Verbal Learning Test. The MMSE and six other cognitive or functional measures were unchanged. Alterations in CSF and blood Aβ and tau levels were reported to be consistent with decreases in Aβ oligomers, although the small study size warrants caution with such conclusions. Participants reported no adverse behavioral effects, discomfort, or changes in blood pressure, body temperature, or MRI measures after treatment (Arendash et al., 2019). The regimen increased blood cytokine levels in four participants with lower baseline levels, and decreased blood cytokine levels in four participants with higher baseline levels (Cao et al., 2022).

This pilot study was followed by four-month and 12-month extensions, with breaks between the treatment periods of eight and five months, respectively. Five participants who received 18 months of TEMT over 2.5 years were reported to show no significant cognitive decline on six cognitive and functional measures, nor in an overall composite analysis, or by caregiver’s assessment. No adverse effects were reported (Arendash et al., 2022).

In October 2020, the company announced that the FDA had granted a Breakthrough Device designation for MemorEM for Alzheimer’s (press release).

No randomized, placebo-controlled, multicenter trials have been conducted to date.

For details on trials, see clinicaltrials.gov.