Study of ALTO-101 in Patients With Schizophrenia

Phase 2

Recruiting

• Conditions: Schizophrenia; Cognitive Impairment
• Interventions: Drug: ALTO-101; Drug: Placebo; Device: ALTO-101 Transdermal Delivery System; Device: Placebo Transdermal Delivery System

• Registration Number: NCT06502964
• Lead Sponsor: Alto Neuroscience

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-11
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-10
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ALTO-101	ALTO-101	10 days administration of ALTO-101T transdermal delivery system
ALTO-101	ALTO-101 Transdermal Delivery System	10 days administration of ALTO-101T transdermal delivery system
Placebo	Placebo	10 days administration of placebo transdermal delivery system
Placebo	Placebo Transdermal Delivery System	10 days administration of placebo transdermal delivery system

Primary Outcome Measures

Name	Time	Method
Theta band activity	Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11	Theta band activity after 5 and 10 days of dosing of ALTO-101T compared to placebo.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo	Treatment Period Day 1 through study completion (an average of 36 days)	Incidence, severity, and relatedness of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and discontinuation due to TEAEs.

Trial Locations

Locations (6)

Site 5038; 🇺🇸 Garden Grove, California, United States

Site 5063; 🇺🇸 Los Angeles, California, United States

Site 5060; 🇺🇸 Hollywood, Florida, United States

Site 5056; 🇺🇸 Chicago, Illinois, United States

Site 5062; 🇺🇸 Gaithersburg, Maryland, United States

Site 5077; 🇺🇸 New York, New York, United States