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

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

HOUSTON, TX, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the "Company" or "Nexalin"), the leader in non-invasive Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the publication of a fourth peer-reviewed article reporting results from clinical research on its 15 mA DIFS™ technology in Alzheimer's disease. The new analysis, published in the Journal of Alzheimer's Disease, found that 15 mA, 40 Hz stimulation delivered with Nexalin's device significantly improved sleep quality in patients with mild Alzheimer's disease compared with sham treatment, with no serious adverse events.

The article, "High-intensity transcranial alternating current stimulation improves sleep quality in patients with mild Alzheimer's disease: Findings from the TRANSFORM-AD study" (Qiao et al., Journal of Alzheimer's Disease, 2026; DOI: 10.1177/13872877261492561), was authored by investigators at Xuanwu Hospital, Capital Medical University and the National Center for Neurological Disorders in Beijing, China. It reports a secondary analysis of the TRANSFORM-AD study (ClinicalTrials.gov NCT03920826), a randomized, double-blind, sham-controlled trial whose earlier results, including improvements in cognitive function and hippocampal theta-gamma coupling, were previously published in Alzheimer's Research & Therapy. The study was funded by the National Key R&D Program of China, and the authors declared no conflicts of interest.

Study Design

Patients with mild Alzheimer's disease were randomized 1:1 to active stimulation or sham, delivered with Nexalin's Gen-2 SYNC 15 mA device. The active group received 30 one-hour sessions of 40 Hz stimulation at a peak-to-peak amplitude of 15 mA, administered twice daily over 15 consecutive days with electrodes placed on the forehead and bilateral mastoids. The sham group followed an identical protocol with zero current output; active and sham devices were indistinguishable in appearance and sensation, and participants, caregivers, outcome assessors and research nurses remained blinded throughout. Sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI), was the pre-specified primary outcome of the analysis, with anxiety, depression and quality of life evaluated as exploratory outcomes. Of the 46 randomized participants, 43 (20 active, 23 sham) completed baseline and post-treatment assessments.

Key Findings

• Significant improvement in sleep quality. After adjustment for baseline scores, patients receiving 15 mA stimulation had PSQI scores 2.34 points lower than the sham group at the end of treatment (95% CI, −3.63 to −1.05; p < 0.001), where lower scores indicate better sleep.
• Within-group change. Mean PSQI in the active group fell from 9.65 to 6.35, a reduction of 3.30 points, or approximately 34%, compared with a reduction of 0.52 points in the sham group.
• Robust across sensitivity analyses. The treatment effect remained significant after additional adjustment for age, sex, education and baseline cognitive scores (−2.56 points; p < 0.001) and in a mixed-model repeated-measures analysis (−2.78 points; p < 0.001).
• Favorable safety and tolerability. No serious adverse events were observed in either group. One patient in the active group reported a transient tingling sensation during the first two sessions, and one patient in the sham group reported transient itching at the first session.
• Exploratory outcomes and limitations. The analysis did not provide conclusive evidence of effects on anxiety, depression or quality of life, which were evaluated as exploratory outcomes. The authors note that participants' low baseline anxiety and depression scores may account for these findings and call for larger, adequately powered trials. They also note that sleep quality was measured with a self-reported questionnaire, that the duration of the effect after treatment is not yet known, and that blinding integrity was not formally assessed.

Why Sleep Matters in Alzheimer's Disease

According to the authors, approximately 45% of individuals with Alzheimer's disease experience sleep-related problems such as insomnia, sleep fragmentation and excessive daytime sleepiness, and a growing body of evidence supports a bidirectional relationship between sleep disturbance and Alzheimer's pathology. According to the Alzheimer's Association, an estimated 7.4 million Americans age 65 and older are living with Alzheimer's disease in 2026. The authors also propose, as a hypothesis for future research, that improved sleep could be associated with enhanced clearance of pathological proteins such as amyloid-beta, which they note were not measured in this study. The investigators describe the study as the first to evaluate high-intensity stimulation for the management of neuropsychiatric symptoms in Alzheimer's disease, and conclude that the therapy "has potential as an effective therapeutic approach for mild AD patients with sleep disorder."

The authors also highlight why intensity matters. Conventional transcranial alternating current stimulation operates at 1–4 mA and, in their words, "predominantly modulate[s] superficial cortical regions," whereas the 15 mA protocol used in TRANSFORM-AD "occupies a unique position" in the field because of its "capacity to deliver electrical currents directly to deep brain structures" such as the hippocampus, insula and amygdala, which we believe is the same deep-brain mechanism that underpins Nexalin's DIFS™ platform. The authors further note that this approach is portable and suitable for home-based administration, while acknowledging a trade-off in spatial focality. They also cite prior research showing that 15 mA, 77.5 Hz stimulation, the approach used in Nexalin's insomnia program, improved sleep quality in patients with chronic insomnia.

Management Commentary

"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," said 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."

"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," Mr. White continued. "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."

A Growing Body of Peer-Reviewed Evidence in Alzheimer's Disease and Dementia

Today's publication joins three previously announced peer-reviewed articles reporting results from clinical research on Nexalin's 15 mA technology in Alzheimer's disease and dementia:

• Alzheimer's Research & Therapy: results of the TRANSFORM-AD randomized controlled trial, reporting improvements in MMSE and MoCA cognitive scores and enhanced hippocampal theta-gamma coupling after 30 sessions of 15 mA, 40 Hz stimulation.
• Journal of Alzheimer's Disease: resting-state fMRI analysis reporting increased regional brain activity and synchronization in the left middle frontal gyrus and right parahippocampal gyrus following treatment.
• Radiology (flagship journal of the Radiological Society of North America): randomized, sham-controlled trial reporting improved cognition together with enhanced hippocampal-cortical connectivity, with cognitive gains correlating with imaging findings.
• Journal of Alzheimer's Disease (today's announcement): secondary analysis of TRANSFORM-AD reporting a statistically significant improvement in sleep quality versus sham, with no serious adverse events.

Nexalin has completed a Q-Submission meeting with the U.S. Food and Drug Administration (FDA) for its Gen-2 SYNC 15 mA device in Alzheimer's disease, in which the Company discussed the potential use of the De Novo classification pathway and received feedback that provides a clear framework for a planned U.S. pilot study. The Gen-2 SYNC device is approved in China, Brazil and Israel. The published Alzheimer's disease evidence base, together with peer-reviewed publications in insomnia (Psychotherapy and Psychosomatics) and ADHD (Molecular Psychiatry), supports the Company's mood-military-memory clinical business plan and its goal of becoming the global leader in non-invasive stimulation of the brain for the treatment of mental health conditions, including Alzheimer's disease and dementia.

The full article is available at https://doi.org/10.1177/13872877261492561.

About Nexalin Technology, Inc.

Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. Nexalin's medical devices are non-invasive and designed to be undetectable to the human body. Nexalin products are developed to provide relief to those afflicted with mental health issues using frequency based bioelectronic medical technology. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin's next-generation devices use a deeper-penetrating waveform designed to enhance patient response with a favorable tolerability profile, which continues to be evaluated in clinical studies. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil and Israel. Additional information about the Company is available at: https://nexalin.com/.

FORWARD-LOOKING STATEMENTS

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). These forward-looking statements relate to future events, future performance, or management's current expectations, beliefs, assumptions, plans, estimates, intentions, or projections relating to the future, and are not guarantees of future performance. Any statements that are not statements of historical fact, or that refer to expectations, projections, or other characterizations of future events or circumstances (including, without limitation, statements containing the words "believes," "expects," "anticipates," "plans," "intends," "will," "may," "could," "should," "would," "designed to," "positioned to," "potential," "targeted," "seeking," "continues," "strategy," "opportunity," "estimates," "projects," "forecasts," "predicts," "outlook," "guidance," or similar expressions, or the negative of such terms), are forward-looking statements. The Gen-2 SYNC device is investigational in the United States and has not been cleared, approved or otherwise authorized by the FDA for any indication. The TRANSFORM-AD study was an investigator-initiated study conducted at a single site; its results may not be replicated in other studies, and the findings described in this press release have not been reviewed by the FDA.

Forward-looking statements in this press release include, but are not limited to, statements regarding: the clinical significance and implications of the published study results; the expected relevance of the published evidence to physicians, patients and regulators; the potential of the Company's technology to treat sleep disturbance, cognitive impairment or other symptoms of Alzheimer's disease and dementia; the Company's planned U.S. pilot study in Alzheimer's disease, the Company’s interpretation of FDA feedback received in its Q-Submission meeting, and its pursuit of a De Novo regulatory pathway and FDA marketing authorization; the Company's beliefs regarding the ability of its devices to penetrate deep brain structures and the anticipated patient response and tolerability of its devices; and the Company's goal of becoming a global leader in non-invasive brain stimulation. These statements are based on Nexalin's current expectations and assumptions as of the date hereof and are subject to significant risks, uncertainties, and other factors, many of which are beyond the Company's control, that could cause actual results to differ materially from those expressed or implied.

Such risks include, but are not limited to: the Company's need for additional capital and its ability to continue as a going concern; the Company's ability to maintain its Nasdaq listing; the possibility that results from secondary analyses, single-site or investigator-initiated studies will not be replicated in larger or controlled trials; the risk that sleep-quality results, which were based on a self-reported questionnaire in 43 evaluable participants and for which the duration of effect after treatment is unknown, may not be durable or reproducible; the risk that the FDA may not accept clinical data generated outside the United States, including the TRANSFORM-AD study conducted in China; the risk that feedback received through the FDA Q-Submission process is non-binding and that the FDA may not agree that the De Novo pathway is available for the Company’s device or with the design of the planned U.S. pilot study; delays in clinical trial enrollment or completion, unfavorable clinical results, and the Company's reliance on third parties to conduct its clinical trials; the risk that the FDA may require additional studies, different endpoints or additional data, or may not grant marketing authorization; the risk that the Company's devices may not demonstrate the anticipated efficacy or may be associated with adverse events; market acceptance of the Company's products; the Company's ability to protect and enforce its intellectual property; competition; and the trading price of the Company's common stock and general market conditions. Additional risks and uncertainties are described under the heading "Risk Factors" in the Company's most recent Annual Report on Form 10-K for the year ended December 31, 2025, and in the Company's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and other filings the Company makes from time to time with the U.S. Securities and Exchange Commission (the "SEC"), available free of charge at www.sec.gov. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to update any forward-looking statement, except as required by law.

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