Publication date: Jun 27, 2025
In this exploratory trial, we identified a robust biomarker for ALTO-203, EEG high-theta/beta ratio, which is a well-validated measure of abnormal cortical arousal and poor attentional control. A higher-than-expected placebo response was observed on the Bond & Lader measurements no significant separation between ALTO-203 and placebo was observed. These findings replicate results from the Phase 1 study in healthy volunteers, where ALTO-203 treatment led to improvements in sustained attention and reductions in the EEG theta/beta ratio. EEG Biomarker of Drug Effect Identified: The theta/beta ratio, a neurophysiological marker linked to attentional control, was confirmed as a key pharmacodynamic readout. The effects of ALTO-203 on reducing theta/beta ratio were significant compared to placebo (25g: p Notably, this biomarker is FDA-cleared for use alongside clinical evaluation in the diagnosis of ADHD, reinforcing its clinical relevance.
| Concepts | Keywords |
|---|---|
| Adam | Alto |
| Ceo | Beta |
| Depressive | Biomarker |
| Neuroscience | Eeg |
| Pharmacokinetic | Exploratory |
| Neuroscience | |
| Observed | |
| Pharmacodynamic | |
| Phase | |
| Placebo | |
| Poc | |
| Ratio | |
| Significant | |
| Theta | |
| Trial |
Semantics
| Type | Source | Name |
|---|---|---|
| drug | DRUGBANK | Nonoxynol-9 |
| disease | MESH | major depressive disorder |
| disease | MESH | anhedonia |
| drug | DRUGBANK | Histamine |
| drug | DRUGBANK | Tropicamide |
| disease | MESH | ADHD |
| disease | MESH | clinical relevance |
| disease | MESH | depression |