Evaluating ALTO-101 for cognitive impairment in schizophrenia

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

This study is testing a new skin patch called ALTO-101 to see if it can help improve thinking skills in people with schizophrenia.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 21 Years to 55 Years
• Sex: All
• Sponsor: Alto Neuroscience (industry)
• Locations: 14 sites (Garden Grove, California and 13 other locations)
• Trial ID: NCT06502964 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical trial is designed to assess the efficacy of ALTO-101, a transdermal delivery system, in improving cognitive processing in patients with schizophrenia. The study employs a double-blind, placebo-controlled, two-way crossover design to compare changes in electroencephalogram (EEG) markers and cognitive measures between the treatment and placebo groups. Additionally, it aims to evaluate the pharmacokinetics, safety, and tolerability of the ALTO-101 formulation in this patient population.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with schizophrenia for at least one year who also experience cognitive impairment.

Not a fit: Patients with unstable medical conditions, acute psychiatric episodes, or other specified psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance cognitive function in patients with schizophrenia, potentially improving their overall quality of life.

How similar studies have performed: While there have been studies on cognitive treatments in schizophrenia, the specific approach of using ALTO-101 in this manner is relatively novel.

Eligibility 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

Where this trial is running

Garden Grove, California and 13 other locations

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

Study contacts

• Study coordinator: Alto Neuroscience

Conditions: Schizophrenia, Cognitive Impairment