Study of ALTO-101 in Patients With Schizophrenia

December 23, 2025 updated by: Alto Neuroscience

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Recruiting
        • Site 5038
        • Contact:
          • Clinical Operations Manager
      • Los Angeles, California, United States, 90015
        • Recruiting
        • Site 5063
        • Contact:
          • Clinical Operations Manager
      • Orange, California, United States, 92868
        • Recruiting
        • Site 5106
        • Contact:
          • Clinical Operations Manager
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Site 5035
        • Contact:
          • Clinical Operations Manager
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Site 5060
        • Contact:
          • Clinical Operations Manager
      • Tampa, Florida, United States, 33629
        • Recruiting
        • Site 5015
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Recruiting
        • Site 5064
        • Contact:
          • Clinical Operations Manager
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Site 5056
        • Contact:
          • Clinical Operations Manager
    • Maryland
      • Gaithersburg, Maryland, United States, 20877
        • Recruiting
        • Site 5062
        • Contact:
          • Clinical Operations Manager
    • Massachusetts
      • Belmont, Massachusetts, United States, 02478
        • Recruiting
        • Site 5124
        • Contact:
          • Clinical Operations Manager
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Site 5077
        • Contact:
          • Clinical Operations Manager
      • New York, New York, United States, 10027
        • Recruiting
        • Site 5108
        • Contact:
          • Clinical Operations Manager
      • New York, New York, United States, 10035
        • Withdrawn
        • Site 5109
      • White Plains, New York, United States, 10605
        • Recruiting
        • Site 5126
        • Contact:
          • Clinical Operations Manager

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALTO-101
10 days administration of ALTO-101T transdermal delivery system
Drug: ALTO-101
ALTO-101 patches
Device: ALTO-101 Transdermal Delivery System
ALTO-101 transdermal delivery system
Placebo Comparator: Placebo
10 days administration of placebo transdermal delivery system
Drug: Placebo
Inactive placebo patches
Device: Placebo Transdermal Delivery System
Placebo transdermal delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Theta band activity
Time Frame: 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.
Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] ALTO-101T compared to placebo
Time Frame: 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.
Treatment Period Day 1 through study completion (an average of 36 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alto Neuroscience

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2024

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 9, 2024

First Posted (Actual)

July 16, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALTO-101-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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