Nexalin Technology Announces New Secondary Analysis of Previously Published Clinical Trial Data Reveals Previously Unreported Improvements in Memory, Comprehension and Language Function in Alzheimer’s Patients; ADAS-Cog Subscale Analysis to Guide Design of Planned U.S. Alzheimer’s Pilot Study
Nexalin’s post-hoc ADAS-Cog subscale review in mild Alzheimer’s patients will be used to refine endpoints and patient selection for a planned U.S. pilot study.
Rhea-AI Summary
Nexalin Technology (NXL) reported a new exploratory, item-level secondary analysis of Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) data from its completed randomized, double-blind, sham-controlled trial of the 15 mA Gen-2 SYNC DIFS™ neurostimulation device in patients with mild Alzheimer’s disease.
The 46‑patient trial’s main results were previously published in the Journal of Alzheimer’s Disease (2024) and Radiology (2025). Among 20 active-arm participants with complete ADAS‑Cog data, 10 achieved an improvement of four or more points at one or more assessments, a threshold widely regarded as clinically meaningful. The largest individual gains, eight points each, occurred in the two most cognitively impaired patients at baseline. Domain‑level review found improvements at three‑month follow‑up in recognition memory, comprehension of spoken language, spoken language ability, word‑finding, and constructional praxis. The company emphasizes that this post‑hoc, descriptive analysis with a small sample and no adjustment for multiple comparisons is hypothesis‑generating and is intended to guide endpoint and patient‑selection strategy for a planned U.S. pilot study.
Positive
- 50% of active-arm patients with complete ADAS-Cog data (10 of 20) achieved an improvement of four or more points at one or more time points, a level widely regarded as clinically meaningful.
- Largest individual ADAS-Cog gains were eight points, seen in the two participants with the greatest baseline cognitive impairment, suggesting higher baseline severity may be associated with larger responses.
- Domain-level benefits persisted three months post-treatment, with improvements reported in recognition memory, spoken language comprehension and ability, word-finding, and constructional praxis at the three‑month follow‑up.
- Earlier endpoints showed statistically significant advantages versus sham on MMSE (P = .001) and MoCA (P = .03), alongside treatment‑associated changes in hippocampal functional connectivity on fMRI.
- Findings are expected to optimize the planned U.S. pilot study by informing endpoint choice and patient-selection strategy for the Gen-2 SYNC™ console in Alzheimer’s disease.
Negative
- Subscale analysis is post-hoc and descriptive, was not prespecified in the trial protocol, and therefore is framed as hypothesis‑generating rather than confirmatory evidence of treatment efficacy.
- Results are based on a small active-arm subset of 20 participants with complete ADAS-Cog assessments, which limits statistical power and generalizability.
- No adjustment was made for multiple comparisons in the item‑level ADAS‑Cog analysis, increasing the risk that some observed domain‑level improvements may be due to chance.
Market Reaction – NXL
Following this news, NXL has declined 15.19%, reflecting a significant negative market reaction. Our momentum scanner has triggered 7 alerts so far, indicating moderate trading interest and price volatility. The stock is currently trading at $5.25.
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Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 23 | clinical award announcement | Positive | -3.2% | Investigator received an award for research involving Nexalin’s DIFS platform. |
| Jun 16 | clinical abstracts accepted | Positive | -2.8% | Two abstracts reported preliminary results across anxiety, depression, insomnia, and quality of life. |
| Jun 10 | Brazil clinical results | Positive | +2.0% | Brazilian trial reported anxiety, depression, sleep, and quality-of-life improvements. |
| Apr 22 | pivotal trial advance | Positive | +7.7% | Company advanced a planned 160-participant pivotal insomnia trial toward enrollment. |
| Feb 24 | pivotal trial announcement | Positive | +15.1% | Company announced a planned 150-participant pivotal HALO Clarity insomnia trial. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Tag-specific clinical-trial announcements produced mixed reactions, with three positive and two negative 24-hour moves.
Key Terms
adas-cog medical
mmse medical
moca medical
functional mri medical
q-submission regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
Further analysis of ADAS-Cog data from the Company’s randomized, sham-controlled clinical trial — previously published in the Journal of Alzheimer’s Disease and in Radiology — identifies specific improvements in cognitive domains associated with memory in Alzheimer’s patients
One half of evaluable active-arm participants achieved a clinically meaningful improvement of four or more points on the ADAS-Cog, with domain-level gains in comprehension, memory and language function still evident three months after treatment ended. The largest individual gains were observed among patients with the greatest cognitive impairment at baseline.
Findings are expected to directly inform endpoint selection and patient-selection strategy for Nexalin’s planned U.S. pilot study of the Gen-2 SYNC™ console in Alzheimer’s disease, following the Company’s completed Q-Submission meeting with the FDA
HOUSTON, Sept. 03, 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 results of an exploratory, item-level analysis of Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) data from its completed randomized, double-blind, sham-controlled clinical trial evaluating the Company’s proprietary 15 milliamp (mA) Gen-2 SYNC DIFS™ neurostimulation device in patients with mild Alzheimer’s disease. The analysis was conducted to guide endpoint selection and patient-selection strategy for the Company’s planned U.S. pilot study in Alzheimer’s disease. A deeper dive into the trial’s cognitive subscales revealed improvements in distinct areas of mental function that are not visible in the aggregate composite score.
Results from the 46-patient trial have been published in two peer-reviewed journals: the Journal of Alzheimer’s Disease (2024) and Radiology (2025). As previously reported, the trial also demonstrated statistically significant improvements versus sham on the Mini-Mental State Examination (MMSE) (P = .001) and the Montreal Cognitive Assessment (MoCA) (P = .03), together with treatment-associated enhancements in functional connectivity between the hippocampus and key cortical regions observed on functional MRI. This secondary analysis examined individual cognitive and functional subscales within the validated assessment ADAS-Cog. While the original publication focused on the predefined primary and secondary endpoints, the additional analysis identified previously unreported improvements across five Alzheimer's disease-related cognitive domains, with gains still evident three months after treatment concluded. Because meaningful changes within individual cognitive domains can be diluted when combined into a single composite figure, the Company conducted a descriptive, item-level analysis of individual participant data from the active treatment arm to better understand which specific domains responded to treatment, and in which patients. The full Radiology study is available at: https://pubs.rsna.org/doi/10.1148/radiol.241463.
Among the 20 active-arm participants with complete assessment data, 10 achieved an improvement of four or more points at one or more assessment points — a threshold widely regarded as clinically meaningful on the ADAS-Cog. The largest individual improvements, of eight points each, were observed in the two participants with the greatest cognitive impairment at baseline, suggesting a potential relationship between baseline disease severity and treatment response. Domain-level review identified improvement patterns concentrated in recognition memory, comprehension of spoken language, spoken language ability, word-finding, and constructional praxis at the three-month follow-up assessment — three months after the final treatment session.
The subscale analysis was post-hoc, exploratory, and descriptive in nature. It was not prespecified in the trial protocol, includes a small number of participants, and has not been adjusted for multiple comparisons. Findings from analyses of this kind are hypothesis-generating rather than evidence of treatment efficacy and are intended to inform the design of future controlled clinical studies.
“The value of this work is that it tells us where to look next,” said Mark White, Chief Executive Officer of Nexalin Technology. “Our published trial demonstrated significant improvements versus sham on the MMSE and MoCA, with corresponding changes on brain imaging. The item-level ADAS-Cog analysis now gives us a more granular map of the cognitive domains in which responses were concentrated — and which patients responded most — and we expect these insights will directly shape endpoint selection and patient-selection strategy as we advance our planned U.S. pilot study with the FDA.”
“Composite scales such as the ADAS-Cog are essential tools, but they can obscure domain-specific effects, particularly in smaller studies,” said Dr. David Owens, Chief Medical Officer of Nexalin Technology. “Examining the data beneath the composite at the item level is a standard and appropriate way to generate hypotheses for the next stage of clinical development. We expect these observations to help us design a more focused and rigorous study, including how we select patients and define endpoints.”
The Company expects to incorporate these findings into the protocol design for its planned U.S. pilot study of the Gen-2 SYNC console in Alzheimer’s disease, building on the feedback received in the Company’s Q-Submission meeting with the FDA, announced on December 3, 2025, and the broader FDA strategy outlined in the Company’s April 15, 2026 announcement. The Company intends to provide further updates as its U.S. Alzheimer’s program advances.
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 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 believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, Oman 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. Forward-looking statements are based on Nexalin’s current expectations, assumptions, estimates, projections, and beliefs as of the date hereof. These statements are subject to significant risks, uncertainties, and other factors, many of which are beyond the Company’s control, that could cause actual results, performance, or achievements to differ materially from those expressed or implied by the forward-looking statements. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this press release.
Forward-looking statements in this press release include, but are not limited to, statements regarding: the interpretation, validation, and clinical significance of the Company’s clinical trial results and of exploratory analyses of such results, including the ADAS-Cog subscale analysis described herein; the Company’s expectation that the subscale findings will inform or shape endpoint selection and patient-selection strategy for its planned U.S. Alzheimer’s pilot study, and that FDA will accept endpoints or enrollment criteria derived from a post-hoc analysis; the Company’s ability to replicate observations from exploratory analyses in larger, randomized, or controlled clinical studies; the design, enrollment, timing, progress, results, and potential outcomes of the Company’s planned U.S. clinical development program in Alzheimer’s disease, which has not commenced, and of the Company’s separate ongoing HALO™ Clarity pivotal study of the Gen-3 HALO device in insomnia; the mechanism of action, depth of penetration, safety profile, and differentiation of Nexalin’s DIFS™ platform, including the Company’s belief that its next-generation waveform will generate enhanced patient response without adverse side effects; the potential for future development, regulatory progress (including the planned De Novo submission for the Gen-3 HALO device in insomnia), and commercialization of the Company’s products and technology; management’s expectations regarding future regulatory submissions, clearances, and approvals; and the Company’s strategic plans, business prospects, capital needs, and ability to continue as a going concern.
Forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond the Company’s control. Such risks include, but are not limited to: the inherent limitations of post-hoc, exploratory, and descriptive subscale analyses, which were not prespecified, have not been adjusted for multiple comparisons, are not powered to establish statistical significance, and may reflect practice effects, placebo response, regression to the mean, or chance findings; the risk that the FDA may not agree with the endpoints, responder definitions, enrollment criteria, or statistical approaches derived from this post-hoc subscale analysis, and that any feedback received in a Q-Submission meeting is non-binding and does not constitute FDA agreement with, or endorsement of, the Company’s proposed study design; the risk that the responder and domain-level observations described herein, which were derived from active-arm participants only and without a corresponding sham-arm comparison, may not be attributable to treatment; uncertainties regarding the design, enrollment, execution, timing, results, and completion of clinical trials, including the HALO™ Clarity pivotal program and the Company’s planned U.S. Alzheimer’s program; the risk that the planned U.S. Alzheimer’s pilot study may not be initiated, may be delayed, or may be materially redesigned, including as a result of FDA feedback, IDE or IRB requirements, site or investigator availability, or the Company’s inability to fund the study; the ability to obtain regulatory clearance or approval from the FDA or other regulatory bodies, including with respect to any planned De Novo submission; the sufficiency of clinical and non-clinical data to support regulatory submissions; the potential for adverse events, safety concerns, or product performance issues; uncertainty regarding the mechanism of action, depth of penetration, and the extent to which preliminary signals will translate into clinical benefit in larger, controlled studies; market acceptance of, and reimbursement for, the Company’s products; the Company’s ability to protect and enforce its intellectual property rights; competition from existing and new treatment alternatives; the Company’s reliance on third-party manufacturers, suppliers, and clinical investigators; the Company’s ability to generate international revenue and to commercialize its products in international markets, and to maintain ongoing compliance with applicable foreign post-market requirements; the Company’s ability to secure adequate funding on acceptable terms to complete its planned clinical, regulatory, and commercial programs; ; and general economic, political, regulatory, and market conditions. Additional risks and uncertainties that could cause actual results to differ materially 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”). Copies of these filings are available free of charge on the SEC’s website at www.sec.gov and on the Company’s investor relations website. New risk factors emerge from time to time, and it is not possible for the Company to predict all such risk factors or to assess the impact of all such risk factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.
All forward-looking statements in this press release are qualified in their entirety by this cautionary statement and the risk factors and other cautionary statements set forth in the Company’s SEC filings referenced above, and speak only as of the date they are made. Except as required by applicable law, the Company undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances, or otherwise, after the date of this press release.
Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com
FAQ
What did Nexalin Technology (NXL) announce about its Alzheimer’s clinical trial data?
Nexalin Technology announced an exploratory, item-level secondary analysis of ADAS-Cog data from its completed randomized, double-blind, sham-controlled trial of the 15 mA Gen-2 SYNC DIFS™ device in mild Alzheimer’s disease, highlighting domain-specific cognitive improvements and plans to use these findings to guide a planned U.S. pilot study.
How many Alzheimer’s patients showed clinically meaningful ADAS-Cog improvements with Nexalin’s Gen-2 SYNC device (NXL)?
Among 20 active-arm participants with complete ADAS-Cog data, 10 patients achieved an improvement of four or more points at one or more assessment points, a change widely regarded as clinically meaningful on this scale. The largest individual gains were eight points in two patients.
Which cognitive domains improved in Nexalin’s Alzheimer’s trial ADAS-Cog subscale analysis for NXL?
Domain-level review found improvement patterns concentrated in recognition memory, comprehension of spoken language, spoken language ability, word-finding, and constructional praxis at the three-month follow-up, which occurred three months after the final treatment session with the Gen-2 SYNC device.
How long did the cognitive benefits last in Nexalin’s Alzheimer’s ADAS-Cog subscale analysis (NXL)?
The company reports that gains in several ADAS-Cog domains were still evident at the three‑month follow‑up assessment, which took place three months after the last treatment session, suggesting persistence of the observed cognitive improvements over that period.
Is Nexalin’s ADAS-Cog subscale analysis in Alzheimer’s disease considered proof of efficacy for NXL’s device?
No. The ADAS-Cog subscale analysis is described as post-hoc, exploratory, and descriptive. It was not prespecified, involves a small sample, and was not adjusted for multiple comparisons. The company characterizes these findings as hypothesis-generating rather than definitive evidence of treatment efficacy.
How will the new ADAS-Cog findings affect Nexalin’s planned U.S. Alzheimer’s pilot study (NXL)?
Nexalin expects to use the item‑level ADAS-Cog insights to guide endpoint selection and patient-selection strategy in its planned U.S. pilot study of the Gen-2 SYNC™ console, building on feedback from its FDA Q-Submission meeting and its broader U.S. regulatory strategy.
What earlier clinical results support Nexalin’s Gen-2 SYNC DIFS device in Alzheimer’s disease (NXL)?
The completed 46-patient trial previously showed statistically significant improvements versus sham on the MMSE (P = .001) and MoCA (P = .03), as well as treatment‑associated enhancements in functional connectivity between the hippocampus and key cortical regions on functional MRI.