Study of ALTO-101 in Patients With Schizophrenia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT06502964

Run by

Alto Neuroscience

People needed

82

Starts

2024-06-11

Expected to finish

2026-03-01

Last updated by the study team

2025-12-26

Who can join

Age: 21 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site 5126 — White Plains, New York, United States (enrolling)
• Site 5063 — Los Angeles, California, United States (enrolling)
• Site 5106 — Orange, California, United States (enrolling)
• Site 5035 — Walnut Creek, California, United States (enrolling)
• Site 5060 — Hollywood, Florida, United States (enrolling)
• Site 5015 — Tampa, Florida, United States (enrolling)
• Site 5064 — Snellville, Georgia, United States (enrolling)
• Site 5056 — Chicago, Illinois, United States (enrolling)
• Site 5062 — Gaithersburg, Maryland, United States (enrolling)
• Site 5124 — Belmont, Massachusetts, United States (enrolling)
• Site 5108 — New York, New York, United States (enrolling)
• Site 5077 — New York, New York, United States (enrolling)
• Site 5038 — Garden Grove, California, United States (enrolling)
• Site 5109 — New York, New York, United States

Full record on ClinicalTrials.gov

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