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

• ClinicalTrials.gov Identifier: NCT05686239
• Recruitment Status: Recruiting
• First Posted: January 17, 2023
• Last Update Posted: August 25, 2023
• Sponsor: Recognify Life Sciences
• Information provided by (Responsible Party): Recognify Life Sciences

Tracking Information

• First Submitted Date: December 28, 2022
• First Posted Date: January 17, 2023
• Last Update Posted Date: August 25, 2023
• Actual Study Start Date: December 8, 2022
• Estimated Primary Completion Date: July 15, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: 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: A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
• 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)

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

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

Intervention

• Drug: RL-007
  investigational study drug
• Drug: Placebo
  placebo capsules matching the appearance and size of the active drug

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 8, 2023): 234
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 15, 2024
• Estimated Primary Completion Date: July 15, 2024 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Gary Walker, PhD; 510-552-0136; cias2@recognify.life

Contact: Matt Pando, PhD; 571-217-1255; cias2@recognify.life

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05686239
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Recognify Life Sciences
• Original Responsible Party: Same as current
• Current Study Sponsor: Recognify Life Sciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Gary Walker, PhD; Recognify Life Sciences

• PRS Account: Recognify Life Sciences
• Verification Date: August 2023