Recruiting
Phase 2

ALTO-101

Sponsor:

Alto Neuroscience

Code:

NCT06502964

Conditions

Schizophrenia

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Not accepted

Interventions

ALTO-101

ALTO-101 Transdermal Delivery System

Placebo

Placebo Transdermal Delivery System

Study Details

Brief 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

Schizophrenia

Cognitive Impairment

Study ID

NCT06502964

Start date

Jun 11, 2024

Status verified date

Dec, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Feb, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ALTO-101

10 days administration of ALTO-101T transdermal delivery system

placebo comparator: Placebo

10 days administration of placebo transdermal delivery system

Interventions

ALTO-101

ALTO-101 patches

ALTO-101 Transdermal Delivery System

ALTO-101 transdermal delivery system

Placebo

Inactive placebo patches

Placebo Transdermal Delivery System

Placebo transdermal delivery system

Primary outcome measure

  • Theta band activity [ Time Frame: Treatment Period 1 - Day 6 and Day 11; Treatment Period 2 - Day 6 and Day 11 ]

Central Contacts and Locations

Central contacts

Alto Neuroscience

650-200-0412clinical@altoneuroscience.com

Locations

Site 5038

Recruiting

Garden Grove, California, United States, 92845

Site 5063

Recruiting

Los Angeles, California, United States, 90015

Site 5106

Recruiting

Orange, California, United States, 92868

Site 5035

Recruiting

Walnut Creek, California, United States, 94596

Site 5060

Recruiting

Hollywood, Florida, United States, 33024

Site 5015

Recruiting

Tampa, Florida, United States, 33629

Site 5064

Recruiting

Snellville, Georgia, United States, 30078

Site 5056

Recruiting

Chicago, Illinois, United States, 60640

Site 5062

Recruiting

Gaithersburg, Maryland, United States, 20877

Site 5124

Recruiting

Belmont, Massachusetts, United States, 02478

Site 5108

Recruiting

New York, New York, United States, 10027

Site 5077

Recruiting

New York, New York, United States, 10032

Site 5126

Recruiting

White Plains, New York, United States, 10605

More Information

Sponsor

Alto Neuroscience

Last update posted

Dec 26, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Alto Neuroscience on 2025-12-26.