Alzheimer’s is an invariably traumatic diagnosis. According to the Alzheimer’s Association, 5.8 million Americans are living with the condition, which is projected to rise to nearly 14 million by 2050. As the sixth leading cause of death in the US, complications from the decline in brain function associated with Alzheimer’s kill more people than breast cancer and prostate cancer combined.

The condition destroys the nerve connections in the brain, making it progressively more difficult for patients to remember things and look after themselves. Beginning with memory lapses, Alzheimer’s can eventually degrade into hallucinations and delusions, which is distressing for both patients and their loved ones.

There is currently no cure for Alzheimer’s disease, although a number of medicines – primarily acetylcholinesterase inhibitors and memantine – may temporarily improve some of the symptoms or slow disease progression.

Now, NeuroEM Theraputics is making waves with its MemorEM headcap, after an early-stage trial indicated that the device could reverse the progression of the disease. The device, worn like a bathing cap and used twice daily for one hour, emits electromagnetic waves into the brain which dissolve abnormal structures that are associated with the disease.

While the initial study was limited in its scope, with only eight participants, the results were promising. When participants were assessed through the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) after two months of MemorEM use, seven of them responded with a four-point increase in cognitive performance. An Alzheimer’s patient typically loses four points on the scale each year.

Aβ and tau clusters

NeuroEM CEO Gary Arendash says: “In order to understand how [MemorEM] operates you need to understand what the root cause of Alzheimer’s disease is. An increasing number of Alzheimer’s researchers believe the root cause is bad proteins made in brain cells. By themselves they’re not dangerous, but as you age they start to aggregate.”

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He is talking about Amyloid-β (Aβ) and tau, the respective building blocks of abnormal brain structures called extracellular amyloid plaques and intraneuronal neurofibrillary tangles. These aggregates are thought to be the root cause of Alzheimer’s disease, interfering with brain function by causing the dysfunction and death of brain cells.

“So far, no one has been able to address these two bad protein aggregates,” says Arendash. “Drugs don’t get into the brain very well and have no way of directly targeting the Aβ and tau.”

MemorEM’s transcranial treatment emits eight different electromagnetic waves directly through the cranium and into the brain, providing the wearer with a full-brain electromagnetic treatment. These electromagnetic waves, unlike drugs, have no problem getting into the brain cells and, according to NeuroEM, disaggregate the structures formed by Aβ and tau clusters.

As well as patients’ drastic four-point improvement on the ADAS-Cog test, cognitive abilities were seen to improve during the Rey Auditory Verbal Learning Test (RAVLT), where a 50% reduction in memory loss was observed.

The study also involved analysis of physical markers of Alzheimer’s in the blood and cerebrospinal fluid (CSF) of patients before and after the two-month period. Four variant biomarkers, three in CSF and one in blood plasma, all reduced in quantity.

Brain scans of individual patients also revealed evidence of increased communication between neurons in the cingulate cortex, a critical brain area for cognitive interaction.

“We’re now doing an extension study with the same patients – they did not want to give up their devices, none of them,” Arendash says. “They’re now getting treatment once a day, not twice a day, for four months.”

Further action required

Of course, the technology remains in very early stages. While it appears to be safe, the study included only eight people and followed them for a very short period of time. Extended research with a larger group of patients will be needed to ensure MemorEM doesn’t do any long-term harm to users.

The trial also cannot be considered as having adequately assessed effectiveness, with so few participants and no control group. One of the eight participants was not seen to gain any benefit from the treatment, so it seems unlikely it will work for everyone. Still, if subsequent study can recreate these results, MemorEM could prove to be a game changer for patients suffering from Alzheimer’s.

It’s also worth noting that the technology, even if it does work for Alzheimer’s, may not work for treating other forms of dementia. Frontotemporal dementia, for example, involves the aggregation of tau but not Aβ so may respond differently to MemorEM, while Lewy body dementia is caused by the aggregation of a third toxic protein called α-synuclein, which the study did not account for.

Arendash, however, remains confident that MemorEM could disaggregate α-synuclein oligomers too, flagging as-yet unpublished data from one of the NeuroEM researchers which indicated this.

“We’d like to think that because we can disaggregate all three of these major toxic proteins within brain cells that we may be able to address more than just Alzheimer’s,” he says. “We could address other dementia variations and cognitive-related disorders like Parkinson’s disease, which has been linked to α-synuclein.

“We’re really focused now on Alzheimer’s and we really want to do our big pivotal trial to hopefully get FDA approval as the first therapeutic against Alzheimer’s. Then we’ll have the ability to spread out into some of these other neurologic disorders.”

NeuroEM hopes to see its device become commercially available by the first half of 2022. It has also submitted international patent applications, and hopes to secure the European CE mark alongside US Food and Drug Administration approval.