A Phase 2 interventional study of ALTO-101 and ALTO-101 Transdermal Delivery System in Schizophrenia and Cognitive Impairment, sponsored by Alto Neuroscience. Recruiting at 14 sites in United States. Open to participants aged 21 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Alto Neuroscience · Phase 2, Interventional, and Treatment
This is a Phase 2, double-blind, placebo-controlled, two-way crossover study to compare the efficacy of ALTO-101T versus placebo in change in electroencephalogram (EEG) cognitive processing markers and measures of cognition.
Additional goals are to assess pharmacokinetic (PK), safety, and tolerability of the recently developed ALTO-101T transdermal delivery system (TDS) formulation in a patient population.
3,470 studies on the registry are indexed under Schizophrenia; 471 are open to participants now.
This study's planned enrollment of 82 is above the median of 70 across 2,871 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Alto Neuroscience is the lead sponsor of 11 studies on the registry; 4 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10 days administration of ALTO-101T transdermal delivery system
Drug: ALTO-101 · Device: ALTO-101 Transdermal Delivery System
10 days administration of placebo transdermal delivery system
Drug: Placebo · Device: Placebo Transdermal Delivery System
ALTO-101 patches
ALTO-101 transdermal delivery system
Inactive placebo patches
Placebo transdermal delivery system
Theta band activity
Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.
Time frame: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo
Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs.
Time frame: Treatment Period Day 1 through study completion (an average of 36 days)
Plan to share: No
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Alto Neuroscience