RecruitingPhase 2NCT06502964

Study of ALTO-101 in Patients With Schizophrenia

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


Sponsor

Alto Neuroscience

Enrollment

82 participants

Start Date

Jun 11, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 21 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called ALTO-101 in people with schizophrenia who are experiencing cognitive impairment (problems with memory and thinking) despite being on stable antipsychotic medications. **You may be eligible if...** - You have been diagnosed with schizophrenia for at least one year - You are experiencing cognitive difficulties related to your condition - You have been on stable doses of 1–2 antipsychotic medications for at least 8 weeks - Your psychotic symptoms are relatively stable (not in an acute flare) - Your BMI is between 18 and 37 - You are willing to comply with all study requirements **You may NOT be eligible if...** - You have an unstable medical condition - You were hospitalized for psychiatric reasons in the past 6 months - You have schizoaffective disorder, bipolar disorder, dementia, or intellectual disability - You are currently experiencing a major depressive episode - You are taking a mood stabilizer, clozapine, or daily benzodiazepines - You have a moderate or severe substance use disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGALTO-101

ALTO-101 patches

DEVICEALTO-101 Transdermal Delivery System

ALTO-101 transdermal delivery system

DRUGPlacebo

Inactive placebo patches

DEVICEPlacebo Transdermal Delivery System

Placebo transdermal delivery system


Locations(14)

Site 5038

Garden Grove, California, United States

Site 5063

Los Angeles, California, United States

Site 5106

Orange, California, United States

Site 5035

Walnut Creek, California, United States

Site 5060

Hollywood, Florida, United States

Site 5015

Tampa, Florida, United States

Site 5064

Snellville, Georgia, United States

Site 5056

Chicago, Illinois, United States

Site 5062

Gaithersburg, Maryland, United States

Site 5124

Belmont, Massachusetts, United States

Site 5108

New York, New York, United States

Site 5077

New York, New York, United States

Site 5109

New York, New York, United States

Site 5126

White Plains, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06502964


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