Evaluating ALTO-101 for cognitive impairment in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Alto Neuroscience
• Email: clinical@altoneuroscience.com
• Phone: 650-200-0412

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.