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
Nexalin announced its fourth peer-reviewed publication on its 15 mA DIFS technology in Alzheimer's disease, published in the Journal of Alzheimer's Disease. The TRANSFORM-AD secondary analysis found PSQI sleep-quality scores 2.34 points better than sham (p < 0.001) with no serious adverse events, using 43 evaluable of 46 randomized participants at a single Chinese site. The company has completed an FDA Q-Submission meeting discussing a potential De Novo pathway and plans a U.S.
Key figures
- Drug Name
- Gen-2 SYNC 15 mA DIFS device
- Phase Of Trial
- Randomized, double-blind, sham-controlled trial (TRANSFORM-AD, secondary analysis)
- Completers
- 43
- Psqi treatment effect
- -2.34 points vs sham (p < 0.001)
- Serious adverse events
- 0
- Randomized participants
- 46
- Psqi active group change
- 9.65 to 6.35 (~34% reduction)
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