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Brain patch trial aims to sharpen thinking in schizophrenia

NCT ID NCT06502964

Symptom relief Sponsor: Alto Neuroscience Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a skin patch called ALTO-101 can improve cognitive function in people with schizophrenia who have thinking problems. About 82 participants will receive either the active patch or a placebo, then switch after a period. The main goal is to see changes in brain wave activity linked to cognition, along with safety and tolerability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALTO-101
What this could lead to
If successful, this could point toward a new treatment for cognitive problems in schizophrenia, potentially improving thinking and daily function.
What could go wrong
This is an early Phase 2 trial with only 82 people. It measures brain activity, not real-world thinking, so even positive results may not translate to meaningful benefits. Side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 82 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Mar 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cognitive impairment Schizophrenia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Site 5015

    RECRUITING

    Tampa, Florida, 33629, United States

  • Site 5035

    RECRUITING

    Walnut Creek, California, 94596, United States

  • Site 5038

    RECRUITING

    Garden Grove, California, 92845, United States

  • Site 5056

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Site 5060

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Site 5062

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Site 5063

    RECRUITING

    Los Angeles, California, 90015, United States

  • Site 5064

    RECRUITING

    Snellville, Georgia, 30078, United States

  • Site 5077

    RECRUITING

    New York, New York, 10032, United States

  • Site 5106

    RECRUITING

    Orange, California, 92868, United States

  • Site 5108

    RECRUITING

    New York, New York, 10027, United States

  • Site 5109

    WITHDRAWN

    New York, New York, 10035, United States

  • Site 5124

    RECRUITING

    Belmont, Massachusetts, 02478, United States

  • Site 5126

    RECRUITING

    White Plains, New York, 10605, United States

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