Overview

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.

Eligibility

Inclusion Criteria:

• Schizophrenia diagnosis for at least one year
• Cognitive impairment
• Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2
• Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening
• Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)
• Willing to comply with all study assessments and procedures

Exclusion Criteria:

• Evidence of unstable medical condition
• Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months
• Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability
• Current episode of major depressive disorder (MDD)
• Use of mood stabilizer, clozapine, and/or daily benzodiazepine
• Current moderate or severe substance use disorder