Skip to content
Bored Studies
RecruitingPhase 2

Study of ALTO-101 in Patients With Schizophrenia

Alto Neuroscience · NCT06502964

View Study & Apply (opens in a new tab)

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
82
US sites recruiting
13
Study start
June 11, 2024
Record last updated
December 26, 2025

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ALTO-101; ALTO-101 Transdermal Delivery System; Placebo; Placebo Transdermal Delivery System

Conditions: Schizophrenia; Cognitive Impairment

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Site 5038

    Garden Grove, CA 92845

    Site contact: Clinical Operations Manager

  • Site 5063

    Los Angeles, CA 90015

    Site contact: Clinical Operations Manager

  • Site 5106

    Orange, CA 92868

    Site contact: Clinical Operations Manager

  • Site 5035

    Walnut Creek, CA 94596

    Site contact: Clinical Operations Manager

  • Site 5060

    Hollywood, FL 33024

    Site contact: Clinical Operations Manager

  • Site 5015

    Tampa, FL 33629

  • Site 5064

    Snellville, GA 30078

    Site contact: Clinical Operations Manager

  • Site 5056

    Chicago, IL 60640

    Site contact: Clinical Operations Manager

  • Site 5062

    Gaithersburg, MD 20877

    Site contact: Clinical Operations Manager

  • Site 5124

    Belmont, MA 02478

    Site contact: Clinical Operations Manager

  • Site 5108

    New York, NY 10027

    Site contact: Clinical Operations Manager

  • Site 5077

    New York, NY 10032

    Site contact: Clinical Operations Manager

  • Site 5126

    White Plains, NY 10605

    Site contact: Clinical Operations Manager

Study contacts (from the official record)

  • Alto Neuroscience · 650-200-0412 · clinical@altoneuroscience.com
All mental health studies in California →
Study of ALTO-101 in Patients With Schizophrenia (NCT06502964) | Bored Studies