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NCT Number: NCT06502964

Study of ALTO-101 in Patients With Schizophrenia

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.

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Key information

Conditions

Schizophrenia Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Neurocognitive Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 5038, Garden Grove, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALTO-101

Drug

ALTO-101 patches

ALTO-101 Transdermal Delivery System

Device

ALTO-101 transdermal delivery system

Placebo

Drug

Inactive placebo patches

Placebo Transdermal Delivery System

Device

Placebo transdermal delivery system

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alto Neuroscience

CONTACT

[email protected]

650-200-0412

Sponsors and collaborators

Lead sponsor

Alto Neuroscience

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2024
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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