# Disaggregation of Toxic Protein Oligomers in Brain with ElectromagneticTreatment

> **NIH NIH R44** · NEUROEM THERAPEUTICS, INC. · 2021 · $1,164,576

## Abstract

PROJECT SUMMARY / ABSTRACT
Alzheimer’s Disease (AD) is the 6th leading cause of death in the U.S., costs the U.S. government over $200B
every year, and has the potential to compromise the U.S. healthcare system within a few decades if an effective
treatment or preventative is not found. Pharmaceutical research has been mostly fruitless, with over 150 drugs
having disappointing results in clinical trials to prevent or treat AD, including several drug failures in 2019 alone.
In recent years, it has become clear that the probable culprits of AD are toxic soluble “oligomers” of b-amyloid
and tau proteins that aggregate inside neurons. Through extensive pre-clinical studies in AD transgenic mice,
the PI and NeuroEM Therapeutics, Inc. have shown that Transcranial Electromagnetic Treatment (TEMT)
penetrates the brain to disaggregate both of these toxic oligomers, while enhancing mitochondrial function and
inducing consistent cognitive benefits. To translate these promising findings to clinical trials, NeuroEM has
created a first-of-its-kind head device (the MemorEM) for in-home treatment. Published results from the
company’s Pilot clinical trial in AD subjects have shown the device to provide considerable cognitive benefit,
changes in Ab levels within CSF consistent with Ab disaggregation in the brain, and evidence of enhanced brain
function in fMRI. In view of these pre-clinical and clinical findings, the FDA has recently granted the MemorEM
device “Breakthrough Device” designation. Given these promising, FDA-acknowledged results, NeuroEM’s
major thrust now is to identify a best set(s) of TEMT parameters for its pivotal clinical trial that are the safest and
most efficacious for disaggregating toxic protein oligomers. NeuroEM’s SBIR Phase I grant elucidated the ability
of TEMT to disaggregate three toxic protein oligomers (Ab, tau, and a-synuclein) in AD brain homogenates and
began determination of the most efficacious TEMT parameters therein. Our proposed SBIR Phase II research
is a logical extension of our SBIR Phase I findings by determining a best set of four TEMT parameters for Ab
disaggregation, and doing so in “cell cultures” studies wherein intra- and extracellular physiologic endpoints can
be evaluated for safety – both of these Phase II goals are important for NeuroEM’s Pivotal clinical trial, wherein
NeuroEM’s MemorEM device will be utilizing this best set of parameters. Accordingly, Phase II studies are
organized into two Specific Aims: Specific Aim 1: Utilizing N2a/APPswe cell cultures, wherein secretion and
aggregation of Ab occurs, establish optimal TEMT parameters (e.g., frequency, power level, etc.) for
disaggregation of Ab; then elucidate Ab-related effects of TEMT on N2a/APPswe cell viability, mitochondrial
function, and protein production. Specific Aim 2: Utilizing three different primary cell cultures (hippocampal
neurons, microglia, PBMC immune cells), evaluate indirect (non-Ab) TEMT actions on a variety of important
physiologic s...

## Key facts

- **NIH application ID:** 10144238
- **Project number:** 9R44AG073096-02A1
- **Recipient organization:** NEUROEM THERAPEUTICS, INC.
- **Principal Investigator:** GARY W ARENDASH
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,164,576
- **Award type:** 9
- **Project period:** 2016-12-15 → 2024-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10144238

## Citation

> US National Institutes of Health, RePORTER application 10144238, Disaggregation of Toxic Protein Oligomers in Brain with ElectromagneticTreatment (9R44AG073096-02A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10144238. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*