Study of ALTO-101 in Patients With Schizophrenia

Description

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.

Conditions

Schizophrenia, Cognitive Impairment

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Study Overview

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Study Details

Study overview

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.

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

Study of ALTO-101 in Patients With Schizophrenia

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Garden Grove

Site 5083, Garden Grove, California, United States, 92845

Hollywood

Site 5060, Hollywood, Florida, United States, 33024

Chicago

Site 5056, Chicago, Illinois, United States, 60640

Gaithersburg

Site 5062, Gaithersburg, Maryland, United States, 20877

Cedarhurst

Site 5055, Cedarhurst, New York, United States, 11516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

21 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alto Neuroscience,

Study Record Dates

2025-11