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NCT06502964PHASE2Recruiting

Study of ALTO-101 in Patients With Schizophrenia

Alto Neuroscience

Start Date

6/11/2024

Completion Date

3/1/2026

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.

Eligibility Criteria

Age Range: 21 years to 55 years

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

Interventions

DRUG

ALTO-101

DEVICE

ALTO-101 Transdermal Delivery System

DRUG

Placebo

DEVICE

Placebo Transdermal Delivery System

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Conditions

SchizophreniaCognitive Impairment

Locations

Site 5038

Garden Grove, California 92845

United States

Site 5063

Los Angeles, California 90015

United States

Site 5106

Orange, California 92868

United States

Site 5035

Walnut Creek, California 94596

United States

Site 5060

Hollywood, Florida 33024

United States

Site 5015

Tampa, Florida 33629

United States

Site 5064

Snellville, Georgia 30078

United States

Site 5056

Chicago, Illinois 60640

United States

Site 5062

Gaithersburg, Maryland 20877

United States

Site 5124

Belmont, Massachusetts 02478

United States

Site 5108

New York, New York 10027

United States

Site 5077

New York, New York 10032

United States

Site 5109

New York, New York 10035

United States

Site 5126

White Plains, New York 10605

United States