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

Study Overview
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Brief Summary
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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: Does RL-007 improve subjects performance in a set of cognitive tasks? Which dose of RL-007 (20 mg or 40 mg) has a larger effect on cognitive performance? 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.

Detailed Description
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This is a randomized, 3-arm, placebo-controlled, double-blinded clinical trial to evaluate the efficacy, safety, and tolerability of RL-007 in subjects with stable schizophrenia. The treatment period is 6 weeks.

Official Title
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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)

Conditions
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Cognitive Impairment Associated With Schizophrenia (CIAS), Cognitive Impairment, Schizophrenia

Intervention / Treatment
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* Drug: RL-007
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Diagnosis of schizophrenia, per Diagnostic and Statistical Manual (DSM) 5, with a duration of at least 6 months Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive) Currently treated on a single atypical antipsychotic (other than clozapine) at a stable dose and clinically stable for at least 6 weeks before randomization Clinical Global Impression - Severity score < 5. Body mass index (BMI) <= 40.0 kg/m^2 at screening 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. Sufficient fluency in English to understand and complete study instructions and assessments Key Exclusion Criteria: History of hospitalization for medical indication or psychiatric hospitalization within 3 months prior to screening. 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. 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). Current diagnosis of another major psychiatric disorder, intellectual disability, or any major neurological disease, brain injury, epilepsy, or severe brain trauma. 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. 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). Participant has undergone electroconvulsive therapy within the past 12 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RL-007 20 mg<br>oral dosing three times per day (TID) | Drug: RL-007<br>* investigational study drug<br>|
| Experimental: RL-007 40 mg<br>oral dosing three times per day (TID) | Drug: RL-007<br>* investigational study drug<br>|
| Placebo Comparator: Placebo<br>oral dosing three times per day (TID) | Drug: Placebo<br>* placebo capsules matching the appearance and size of the active drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite | change from baseline in composite of nine cognitive tests | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symbol Coding | change from baseline | 6 weeks | 
| The Speed of Processing domain of the MCCB | change from baseline | 6 weeks | 
| The Attention/Vigilance domain of the MCCB | change from baseline | 6 weeks | 
| The Working Memory domain of the MCCB | change from baseline | 6 weeks | 
| The Verbal Memory domain of the MCCB | change from baseline | 6 weeks | 
| The Visual Learning domain of the MCCB | change from baseline | 6 weeks | 
| The Reasoning and Problem-solving domain of the MCCB | change from baseline | 6 weeks | 
| Clinical Global Impression - Severity (CGI-S) | change from baseline | 6 weeks |