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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cognitive Impairment Associated With Schizophrenia (CIAS) Cognitive Impairment Schizophrenia Drug: RL-007 Drug: Placebo Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 8, 2022
Estimated Primary Completion Date : July 15, 2024
Estimated Study Completion Date : November 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Experimental: RL-007 20 mg
oral dosing three times per day (TID)
 Drug: RL-007
investigational study drug
Experimental: RL-007 40 mg
oral dosing three times per day (TID)
 Drug: RL-007
investigational study drug
Placebo Comparator: Placebo
oral dosing three times per day (TID)
 Drug: Placebo
placebo capsules matching the appearance and size of the active drug


Outcome Measures
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Primary Outcome Measures :
  1. MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite [ Time Frame: 6 weeks ]
    change from baseline in composite of nine cognitive tests


Secondary Outcome Measures :
  1. Symbol Coding [ Time Frame: 6 weeks ]
    change from baseline

  2. The Speed of Processing domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline

  3. The Attention/Vigilance domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline

  4. The Working Memory domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline

  5. The Verbal Memory domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline

  6. The Visual Learning domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline

  7. The Reasoning and Problem-solving domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline

  8. Clinical Global Impression - Severity (CGI-S) [ Time Frame: 6 weeks ]
    change from baseline


Other Outcome Measures:
  1. Safety measures [ Time Frame: 6 weeks ]
    Treatment Emergent Adverse Events

  2. The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) [ Time Frame: 6 weeks ]
    change from baseline

  3. The Social Cognition domain of the MCCB [ Time Frame: 6 weeks ]
    change from baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05686239


Contacts
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Contact: Gary Walker, PhD 510-552-0136 cias2@recognify.life
Contact: Matt Pando, PhD 571-217-1255 cias2@recognify.life

Locations
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United States, California
Recognify Research Site Recruiting
Culver City, California, United States, 90230
Contact: PI         
Collaborative Neuroscience Research Recruiting
Garden Grove, California, United States, 92845
Contact: David Walling, PhD    714-799-7799      
Principal Investigator: David Walling, PhD         
Recognify Research Site Recruiting
Lafayette, California, United States, 94549
Contact: PI         
125 Clairemont Avenue Recruiting
Oceanside, California, United States, 92056
Contact: PI         
Recognify Research Site Recruiting
Orange, California, United States, 92868
Contact: PI         
Recognify Research Site Recruiting
Torrance, California, United States, 90502
Contact: PI         
United States, Florida
Recognify Research Site Recruiting
Clermont, Florida, United States, 34711
Contact: PI         
Recognify Research Site Recruiting
Hialeah, Florida, United States, 33016
Contact: PI         
Recognify Research Site Recruiting
Miami Lakes, Florida, United States, 33016
Contact: PI         
125 Clairemont Avenue Recruiting
Miami, Florida, United States, 33135
Contact: PI         
United States, Georgia
Recognify Research Site Recruiting
Atlanta, Georgia, United States, 30030
Contact: PI         
Recognify Research Site Recruiting
Augusta, Georgia, United States, 30912
Contact: PI         
United States, Maryland
Recognify Research Site Recruiting
Gaithersburg, Maryland, United States, 20877
Contact: PI         
United States, New Jersey
Recognify Research Site Recruiting
Berlin, New Jersey, United States, 08009
Contact: PI         
United States, New York
125 Clairemont Avenue Recruiting
Brooklyn, New York, United States, 11235
Contact: PI         
United States, North Carolina
Recognify Research Site Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: PI         
United States, Ohio
Recognify Research Site Recruiting
Cincinnati, Ohio, United States, 45219
Contact: PI         
Recognify Research Site Recruiting
Cleveland, Ohio, United States, 44122
Contact: PI         
United States, Texas
Recognify Research Site Recruiting
Dallas, Texas, United States, 75231
Contact: PI         
125 Clairemont Avenue Recruiting
Houston, Texas, United States, 77074
Contact: PI         
United States, Washington
Recognify Research Site Recruiting
Everett, Washington, United States, 98201
Contact: PI         
Sponsors and Collaborators
Recognify Life Sciences
Investigators
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Study Director: Gary Walker, PhD Recognify Life Sciences
More Information
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Responsible Party: Recognify Life Sciences
ClinicalTrials.gov Identifier: NCT05686239    
Other Study ID Numbers: C07-03-02
First Posted: January 17, 2023    Key Record Dates
Last Update Posted: August 25, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
 Mental Disorders
Cognition Disorders
Neurocognitive Disorders