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RECRUITING
NCT06502964
PHASE2

Study of ALTO-101 in Patients With Schizophrenia

Sponsor: Alto Neuroscience

View on ClinicalTrials.gov

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.

Official title: Double-Blind, Placebo-Controlled Study of ALTO-101 in Patients With Schizophrenia and Cognitive Impairment

Key Details

Gender

All

Age Range

21 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

82

Start Date

2024-06-11

Completion Date

2026-03

Last Updated

2025-12-26

Healthy Volunteers

No

Interventions

DRUG

ALTO-101

ALTO-101 patches

DEVICE

ALTO-101 Transdermal Delivery System

ALTO-101 transdermal delivery system

DRUG

Placebo

Inactive placebo patches

DEVICE

Placebo Transdermal Delivery System

Placebo transdermal delivery system

Locations (14)

Site 5038

Garden Grove, California, United States

Site 5063

Los Angeles, California, United States

Site 5106

Orange, California, United States

Site 5035

Walnut Creek, California, United States

Site 5060

Hollywood, Florida, United States

Site 5015

Tampa, Florida, United States

Site 5064

Snellville, Georgia, United States

Site 5056

Chicago, Illinois, United States

Site 5062

Gaithersburg, Maryland, United States

Site 5124

Belmont, Massachusetts, United States

Site 5108

New York, New York, United States

Site 5077

New York, New York, United States

Site 5109

New York, New York, United States

Site 5126

White Plains, New York, United States