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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05686239
Recruitment Status : Recruiting
First Posted : January 17, 2023
Last Update Posted : August 25, 2023
Sponsor:
Information provided by (Responsible Party):
Recognify Life Sciences

Tracking Information
First Submitted Date  ICMJE December 28, 2022
First Posted Date  ICMJE January 17, 2023
Last Update Posted Date August 25, 2023
Actual Study Start Date  ICMJE December 8, 2022
Estimated Primary Completion Date July 15, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2023)
MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite [ Time Frame: 6 weeks ]
change from baseline in composite of nine cognitive tests
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2023)
  • Symbol Coding [ Time Frame: 6 weeks ]
    change from baseline
  • The Speed of Processing domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline
  • The Attention/Vigilance domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline
  • The Working Memory domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline
  • The Verbal Memory domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline
  • The Visual Learning domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline
  • The Reasoning and Problem-solving domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline
  • Clinical Global Impression - Severity (CGI-S) [ Time Frame: 6 weeks ]
    change from baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 8, 2023)
  • Safety measures [ Time Frame: 6 weeks ]
    Treatment Emergent Adverse Events
  • The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) [ Time Frame: 6 weeks ]
    change from baseline
  • The Social Cognition domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
Official Title  ICMJE 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)
Brief Summary

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.

Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cognitive Impairment Associated With Schizophrenia (CIAS)
  • Cognitive Impairment
  • Schizophrenia
Intervention  ICMJE
  • Drug: RL-007
    investigational study drug
  • Drug: Placebo
    placebo capsules matching the appearance and size of the active drug
Study Arms  ICMJE
  • Experimental: RL-007 20 mg
    oral dosing three times per day (TID)
    Intervention: Drug: RL-007
  • Experimental: RL-007 40 mg
    oral dosing three times per day (TID)
    Intervention: Drug: RL-007
  • Placebo Comparator: Placebo
    oral dosing three times per day (TID)
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2023)
234
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2024
Estimated Primary Completion Date July 15, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gary Walker, PhD 510-552-0136 cias2@recognify.life
Contact: Matt Pando, PhD 571-217-1255 cias2@recognify.life
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05686239
Other Study ID Numbers  ICMJE C07-03-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Recognify Life Sciences
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Recognify Life Sciences
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gary Walker, PhD Recognify Life Sciences
PRS Account Recognify Life Sciences
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP