NERVE STIMULATION DURING SLEEP: A BREAKTHROUGH TREATMENT FOR ALZHEIMER'S AND DEMENTIA

A quiet revolution while you sleep
Dementia, and particularly Alzheimer's disease, remains one of the most devastating conditions, affecting not only patients but also their families, caregivers and healthcare systems worldwide. Despite major efforts, no treatment has yet succeeded in significantly halting cognitive decline.
Cogniguard offers an innovative approach: slowing the progression of the disease through non-invasive vagus nerve stimulation (VNS). This is a technology that is well-established in treating epilepsy, depression, migraine and heart disease.

It is Dr. Tamir Ben David, founder and president of Cogniguard, who recognized the potential of this technology in brain-related disorders. "A key problem in Alzheimer's disease is the disruption of memory consolidation," he explains. "This mainly occurs during REM sleep. I realized that if we could enhance the release of neurotransmitters in the brain during sleep, we may be able to restore the brain's natural memory-building processes."

Vguard: imperceptible treatment, remarkable results
Vguard emerged from this insight. A lightweight headband device worn during sleep, it provides neural stimulation, below sensation threshold, through the night. Comfortable and easy to use, the device connects to the vagus nerve through the ear via an external small electrode, and operates automatically while the user sleeps.

"The current is so weak that users don't feel a thing," says Cogniguard CEO Ehud Raivitz. "Some even wake in the morning, start their daily routine, and only later realized they're still wearing it!"

Preclinical animal studies have shown vagus nerve stimulation triggering increased activity in the hippocampus, the brain's memory center, producing the theta waves associated with memory consolidation.

Results were also clear from a clinical trial in Poland with 51 patients. The treatment group experienced significant improvement, whereas the control group either declined or showed no change. Some in the treatment group even returned to work, resumed driving and regained independence, describing the Vguard as "life-changing."

From early intervention to slowing decline
Dr. Ben David, an expert in cardiology and neural stimulation, calls Alzheimer's disease "the final frontier" among brain disorders without effective treatment. "Vguard doesn't cure the disease," he emphasizes, "but it may slow its progression and even reduce brain inflammation, a major factor in its development."

Following the successful trial in Poland, a follow-up study was conducted at the Israeli Alzheimer's Medical Center involving 14 patients, again with positive results. During the past year, Cogniguard has received European CE certification.

Cogniguard is currently raising $5 million to support upcoming clinical trials in Europe and is actively engaging with the FDA to finalize the protocol for its pivotal study in the United States.

When should patients begin using Vguard?
"The disease develops silently for a decade or more before symptoms appear," explains Dr. Ben David. "Today, there's a simple blood test that can detect it onset in its early stages, but until now, there wasn't much we could do with that information. It's in these pre-symptomatic or early stages that Vguard can be proactively used to help preserve brain function."

And in advanced stages?
"At later stages, its use becomes more complex because patients may remove the device without understanding its purpose," says Raivitz. "That's why early intervention is important. The earlier you start, the greater the potential for improvement. We've seen patients regain abilities that once seemed lost, dressing themselves, engaging with their surroundings, watching TV."

From heart to brain: an Israeli vision
"We see the Vguard as a true medical breakthrough coming out of Israel," says Dr. Ben David. "Just as Israel became a world leader in cardiac care, we're now moving from the heart to the brain using innovative, patented technology."

"Next year, we plan an initial rollout in Europe and Israel, and we're inviting partners to join this incredible journey," adds Raivitz. "With over 55 million people worldwide affected by Alzheimer's or dementia, the economic burden is projected to reach $15 trillion by 2050. I don't think there's a more promising medical market today. Once FDA approval is obtained, the market potential for our product is enormous."

Cogniguard currently has a staff of 15. Technological R&D is conducted in Israel, and clinical operations are based in Poland to support European market entry. Cogniguard is part of the Shizim Group Innovation Center. Shizim serves as a co-founder and investor.

Further information

In collaboration with Cogniguard