COMPLETED

A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)

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

The goal of this clinical trial is to evaluate if the investigational drug, RL-007, can improve the cognitive performance of subjects with schizophrenia. The main questions the study aims to answer are: 1. Does RL-007 improve subjects performance in a set of cognitive tasks? 2. Which dose of RL-007 (20 mg or 40 mg) has a larger effect on cognitive performance? 3. How well do subjects tolerate RL-007? In the study, subjects will perform the cognitive tasks at the beginning to get familiar with the tasks. Then, subjects will be given either RL-007 or a placebo for 6 weeks and then repeat the cognitive tasks. The researchers will compare the results at the end of the treatment period to the baseline to see if there have been any changes in performance. Additionally, several safety measures will be collected throughout the study (blood pressure, physical exam, ECGs, etc) to evaluate if there are any side effects from taking RL-007.

Official Title

An Adaptive, Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)

Quick Facts

Study Start:2022-12-08
Study Completion:2025-04-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05686239

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:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of schizophrenia, per Diagnostic and Statistical Manual (DSM) 5, with a duration of at least 6 months
  2. * Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive)
  3. * Currently treated on a single atypical antipsychotic (other than clozapine) at a stable dose and clinically stable for at least 6 weeks before randomization
  4. * Clinical Global Impression - Severity score \< 5.
  5. * Body mass index (BMI) \<= 40.0 kg/m\^2 at screening
  6. * Participant has reliable housing that is not expected to change during the study period with no expected significant life events that could affect study outcomes throughout entire study period.
  7. * Sufficient fluency in English to understand and complete study instructions and assessments
  1. * History of hospitalization for medical indication or psychiatric hospitalization within 3 months prior to screening.
  2. * Participants who present a serious risk of suicide, as evidenced by a) "yes" on items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) and meeting these criteria within the past 6 months, or b) posing a significant suicide risk in the Investigator's judgement.
  3. * Participants who present a risk of serious harm to others, as evidence by any history within the past 2 years and any expressed homicidal ideation (with or without plan).
  4. * Current diagnosis of another major psychiatric disorder, intellectual disability, or any major neurological disease, brain injury, epilepsy, or severe brain trauma.
  5. * Evidence or history of significant cognitive impairment, other than associated with schizophrenia, that in the judgement of the Investigator or Sponsor would confound interpretation of study data or prevent safe and satisfactory completion of the study protocol.
  6. * Meets criteria for moderate to severe substance/drug abuse disorder (including alcohol) per DSM-5 within the last 6 months prior to informed consent or a positive alcohol breath test or urine test for drugs of abuse at either Screening or Randomization Visits (except for benzodiazepines taken according to prescription and as an ongoing, stable regimen).
  7. * Participant has undergone electroconvulsive therapy within the past 12 months.

Contacts and Locations

Principal Investigator

Gary Walker, PhD
STUDY_DIRECTOR
Recognify Life Sciences

Study Locations (Sites)

Recognify Research Site
Culver City, California, 90230
United States
Collaborative Neuroscience Research
Garden Grove, California, 92845
United States
Recognify Research Site
Lafayette, California, 94549
United States
Recognify Research Site
Oceanside, California, 92056
United States
Recognify Research Site
Orange, California, 92868
United States
Recognify Research Site
Torrance, California, 90502
United States
Recognify Research Site
Hialeah, Florida, 33016
United States
Recognify Research Site
Miami Lakes, Florida, 33016
United States
Recognify Research Site
Miami, Florida, 33135
United States
Recognify Research Site
Atlanta, Georgia, 30030
United States
Recognify Research Site
Augusta, Georgia, 30912
United States
Recognify Research Site
Gaithersburg, Maryland, 20877
United States
Recognify Research Site
Berlin, New Jersey, 08009
United States
Recognify Research Site
Brooklyn, New York, 11235
United States
Recognify Research Site
Chapel Hill, North Carolina, 27599
United States
Recognify Research Site
Cincinnati, Ohio, 45219
United States
Recognify Research Site
Cleveland, Ohio, 44122
United States
Recognify Research Site
Dallas, Texas, 75231
United States
Recognify Research Site
Houston, Texas, 77074
United States
Recognify Research Site
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Recognify Life Sciences

  • Gary Walker, PhD, STUDY_DIRECTOR, Recognify Life Sciences

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 Date2022-12-08
Study Completion Date2025-04-09

Study Record Updates

Study Start Date2022-12-08
Study Completion Date2025-04-09

Terms related to this study

Additional Relevant MeSH Terms

  • Cognitive Impairment Associated With Schizophrenia (CIAS)
  • Cognitive Impairment
  • Schizophrenia