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Study of ALTO-101 for Schizophrenia and Cognitive Impairment

This study is testing a new patch called ALTO-101 for people with schizophrenia and cognitive impairment (problems with thinking, learning, and memory). Researchers want to see if ALTO-101 helps improve brain activity related to thinking, compared to a placebo (an inactive patch). They are also checking how safe ALTO-101 is and how well your body handles it. You may be able to join if you are 21-55 years old, have had schizophrenia for at least a year, have cognitive impairment, and are on stable doses of 1-2 antipsychotic medications. The study aims to enroll 82 participants.

Study design
This is a Phase 2 study that will compare ALTO-101 patches to inactive placebo patches. It is a "double-blind" study, meaning neither you nor your doctors will know if you are receiving ALTO-101 or placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures brain activity markers on Day 6 and Day 11 of each treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06502964

Study of ALTO-101 in Patients With Schizophrenia

Recruiting
PHASE2Ages 21–55InterventionalTreatment
Alto Neuroscience
~82 participants
Updated 2025-12-26 on ClinicalTrials.gov
What's tested:ALTO-101ALTO-101 Transdermal Delivery SystemPlaceboPlacebo Transdermal Delivery System

At a glance

Recruiting sites
13 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Theta band activity
Measured over Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11

Conditions

Schizophrenia
Cognitive Impairment

Explore related trials

Cognitive DysfunctionSchizophrenia

Where it's being run

14 sites across 7 states
California4
New York4
Florida2
Georgia1
Illinois1
Maryland1
Massachusetts1

Who to contact

Alto Neuroscience
[email protected]
650-200-0412
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Theta band activityTreatment 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.