Nexalin Reports New Cognitive Improvements In Alzheimer's Analysis, Plans U.S. Pilot Study
(RTTNews) - Nexalin Technology, Inc. (NXL), announced results from a secondary analysis of data from its randomized, sham-controlled clinical trial of the Gen-2 SYNC DIFS device in patients with mild Alzheimer's disease.
The exploratory analysis of ADAS-Cog data identified previously unreported improvements in memory, comprehension, language and other cognitive functions, with several benefits remaining evident three months after treatment ended.
ADAS-Cog Analysis
Among 20 active-arm participants with complete assessment data, 10 achieved a clinically meaningful improvement of four or more points on the ADAS-Cog at one or more assessment points.
The largest individual improvement was eight points, observed in two participants who had the greatest cognitive impairment at baseline.
Domain-level improvements were identified in recognition memory, comprehension of spoken language, spoken language ability, word-finding and constructional praxis.
Previous Clinical Findings
The underlying 46-patient trial had previously been published in the Journal of Alzheimer's Disease and Radiology.
Nexalin said the study demonstrated statistically significant improvements versus sham on the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), with corresponding treatment-associated changes in functional connectivity between the hippocampus and key cortical regions observed through functional MRI.
The company said the new analysis provides additional insight into which cognitive domains may respond to treatment and which patients may experience the greatest benefit.
U.S. Alzheimer's Pilot Study
Nexalin plans to incorporate the findings into the design of a planned U.S. pilot study evaluating its Gen-2 SYNC console in Alzheimer's disease.
The analysis is expected to help guide endpoint selection and patient-selection strategy.
The company will build on feedback received during its completed Q-Submission meeting with the FDA as it advances the planned U.S. study.
Exploratory Findings
Nexalin emphasized that the ADAS-Cog subscale analysis was post-hoc, exploratory and descriptive, involving a small number of participants and without adjustment for multiple comparisons.
The findings are therefore considered hypothesis-generating rather than evidence of treatment efficacy and are intended to inform future controlled clinical studies.
NXL has traded between $5.24 and $60.00 over the past year. The stock is currently trading at $5.44, down 12.12%.
