Study of ALTO-101 in Patients With Schizophrenia

Launched by ALTO NEUROSCIENCE · Jul 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ALTO-101 for patients with schizophrenia and related cognitive impairments. The trial aims to see how effective ALTO-101 is compared to a placebo (a treatment that has no active ingredients) in improving brain activity and cognitive functions. Participants will use a special skin patch to receive the medication, and the study will also look at how safe it is and how the body processes the medication.

To be eligible for this study, participants should have a diagnosis of schizophrenia for at least a year and experience some cognitive difficulties. They must be on stable doses of 1-2 antipsychotic medications for at least 8 weeks before joining the trial. Participants should also have a certain level of functioning based on specific ratings. It's important to note that individuals with certain other psychiatric conditions or those currently using specific medications may not qualify for the study. Participants can expect to undergo assessments and procedures as part of the trial, and the study is currently recruiting individuals aged 18 to 65.

Gender

ALL

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