RECRUITING

Study of ALTO-101 in Patients With Schizophrenia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-07
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06502964

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.

Ages Eligible for Study:21 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Schizophrenia diagnosis for at least one year
  2. * Cognitive impairment
  3. * Stable doses of 1-2 antipsychotic medication(s) for at least 8 weeks at Visit 2
  4. * Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 during screening
  5. * Have a body mass index (BMI) ≥ 18.0 and ≤ 37.0 kg/m2 (inclusive)
  6. * Willing to comply with all study assessments and procedures
  1. * Evidence of unstable medical condition
  2. * Acute psychiatric decompensation or severity of symptoms requiring psychiatric hospitalization in past 6 months
  3. * Diagnosis of schizoaffective or bipolar affective disorder, dementia, or intellectual disability
  4. * Current episode of major depressive disorder (MDD)
  5. * Use of mood stabilizer, clozapine, and/or daily benzodiazepine
  6. * Current moderate or severe substance use disorder

Contacts and Locations

Study Contact

Alto Neuroscience
CONTACT
650-200-0412
clinical@altoneuroscience.com

Study Locations (Sites)

Site 5083
Garden Grove, California, 92845
United States
Site 5060
Hollywood, Florida, 33024
United States
Site 5056
Chicago, Illinois, 60640
United States
Site 5062
Gaithersburg, Maryland, 20877
United States
Site 5055
Cedarhurst, New York, 11516
United States

Collaborators and Investigators

Sponsor: Alto Neuroscience

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07
Study Completion Date2025-11

Study Record Updates

Study Start Date2024-07
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia
  • Cognitive Impairment