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Study of ALTO-101 in Patients With Schizophrenia

NCT06502964 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-12-26

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Alto Neuroscience

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-11
Primary Completion
2026-02-28
Completion
2026-03-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06502964 on ClinicalTrials.gov