Nexalin reports ADAS-Cog subscale gains ahead of Alzheimer's pilot
Nexalin Technology has published findings from an exploratory secondary analysis of ADAS-Cog data gathered during its completed randomised, double-blind, sham-controlled trial of the Gen-2 SYNC neurostimulation device in mild Alzheimer's disease. The Houston-based company said the item-level review identified improvements across five cognitive domains that were not apparent in the aggregate composite score, and that the findings will directly inform endpoint and patient-selection strategy for a planned US pilot study.
Among the 20 active-arm participants with complete assessment data, 10 achieved a gain of four or more points on the ADAS-Cog at one or more time points, a threshold the company describes as widely accepted as clinically meaningful. Domain-level improvements in recognition memory, comprehension of spoken language, spoken language ability, word-finding, and constructional praxis were still evident at the three-month follow-up assessment, three months after the final treatment session. The two participants with the greatest baseline cognitive impairment recorded the largest individual gains of eight points each.
What the analysis does and does not show
Nexalin is transparent that the analysis was post-hoc, exploratory, and descriptive. It was not prespecified in the trial protocol, was drawn from a small number of participants, and was not adjusted for multiple comparisons. The company's own release emphasises that findings of this kind are hypothesis-generating rather than evidence of treatment efficacy.
The underlying trial data have been published in two peer-reviewed journals: the Journal of Alzheimer's Disease in 2024 and Radiology in 2025. The previously reported primary and secondary endpoints showed statistically significant improvements versus sham on the Mini-Mental State Examination (p=0.001) and the Montreal Cognitive Assessment (p=0.03), alongside functional MRI evidence of enhanced hippocampal-cortical connectivity.
Chief executive Mark White said the item-level analysis provided "a more granular map of the cognitive domains in which responses were concentrated" and would shape how the company selects patients and defines endpoints for the US pilot study. Chief medical officer David Owens noted that examining data beneath a composite scale at the item level is "a standard and appropriate way to generate hypotheses for the next stage of clinical development."
Regulatory path and competitive context
Nexalin has completed a Q-Submission meeting with the FDA, announced in December 2025, and has outlined a broader US regulatory strategy. The Gen-2 SYNC device holds regulatory approval in China, Brazil, Oman, and Israel, but not yet in the United States.
The broader non-invasive neurostimulation space for Alzheimer's disease is increasingly active, with several research groups and companies pursuing transcranial magnetic stimulation, transcranial direct current stimulation, and sensory-entrainment approaches. Nexalin's DIFS platform, which the company says can reach deep midbrain structures at 15 milliamps, is positioned as differentiated from surface-level devices, though that claim has not yet been validated in a powered, controlled US study.
With a 46-patient completed trial, two peer-reviewed publications, and a completed Q-Submission, Nexalin's Alzheimer's programme is at an early but structured stage. Investors and clinicians will look for the pilot study protocol, including its powered endpoints and enrolment criteria, as the next meaningful milestone.