Nexalin Technology Announces Fourth Peer-Reviewed Publication in Alzheimer's Disease: 15 mA DIFS™ Significantly Improves Sleep Quality in Patients with Mild Alzheimer's Disease
Globe Newswire•27/10/2026•09:00 ET
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Key Highlights
- ➤15 mA stimulation cut PSQI scores 2.34 points versus sham, p < 0.001
- ➤Active-group sleep scores fell 3.30 points, approximately 34%, after treatment
- ➤43 participants completed assessments; no serious adverse events occurred in either group
- ➤FDA Q-Submission feedback supports Nexalin’s planned U.S. Alzheimer’s pilot study framework
- ➤Gen-2 SYNC device is approved in China, Brazil and Israel
Expert Statements
Mark White, Chief Executive Officer of Nexalin Technology
“This fourth peer-reviewed publication on our 15 mA waveform in Alzheimer’s disease extends the story from cognition and brain networks to one of the most burdensome symptoms families face every day: sleep,”
Mark White, Chief Executive Officer of Nexalin Technology
“A statistically significant improvement in sleep quality, achieved with a non-invasive, drug-free, 15-day course of treatment and no serious adverse events, is exactly the kind of evidence we believe will matter to physicians, patients and regulators.”
Mark White, Chief Executive Officer of Nexalin Technology
“Each of these four publications, in Alzheimer’s Research & Therapy, Radiology and now two in the Journal of Alzheimer’s Disease, reports results from blinded, sham-controlled research, including multiple analyses of the same TRANSFORM-AD study, and together we believe they point to the same conclusion: delivering 15 mA of current to deep brain structures produces measurable changes in how the Alzheimer’s brain functions,”
Mark White, Chief Executive Officer of Nexalin Technology
“As we plan our U.S. pilot study following our Q-Submission meeting with the FDA, we believe Nexalin is building a growing published evidence base in non-invasive brain stimulation for Alzheimer’s disease.”
Results from the randomized, double-blind, sham-controlled TRANSFORM-AD study published in the Journal of Alzheimer's Disease, a recognized international peer-reviewed journal
Statistically significant improvement in sleep quality versus sham (p < 0.001) with no serious adverse events; authors describe the study as the first to evaluate high-intensity stimulation for neuropsychiatric symptoms in Alzheimer's disease
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