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

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)

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Cognitive Impairment; Cognitive Impairment Associated With Schizophrenia (CIAS)
• Intervention / Treatment: Drug: Placebo; Drug: RL-007 (Inidascamine)

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
• Enrollment (Actual): 242
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Burgas, Bulgaria
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  • Kardzhali, Bulgaria
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  • Pleven, Bulgaria
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  • Plovdiv, Bulgaria
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  • Sofia, Bulgaria
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  • Varna, Bulgaria
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  • Varna, Bulgaria
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• Czechia
  • Plzen, Czechia
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  • Prague, Czechia
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  • Prague, Czechia
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• Poland
  • Gdansk, Poland
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  • Gorlice, Poland
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  • Kielce, Poland
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  • Lublin, Poland
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  • Poznań, Poland
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  • Łódź, Poland
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• United States
  • California
    • Culver City, California, United States, 90230
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    • Garden Grove, California, United States, 92845
      • Collaborative Neuroscience Research
    • Lafayette, California, United States, 94549
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    • Oceanside, California, United States, 92056
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    • Orange, California, United States, 92868
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    • Torrance, California, United States, 90502
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  • Florida
    • Hialeah, Florida, United States, 33016
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    • Miami, Florida, United States, 33135
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    • Miami Lakes, Florida, United States, 33016
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  • Georgia
    • Atlanta, Georgia, United States, 30030
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    • Augusta, Georgia, United States, 30912
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  • Maryland
    • Gaithersburg, Maryland, United States, 20877
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  • New Jersey
    • Berlin, New Jersey, United States, 08009
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  • New York
    • Brooklyn, New York, United States, 11235
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  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
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  • Ohio
    • Cincinnati, Ohio, United States, 45219
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    • Cleveland, Ohio, United States, 44122
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  • Texas
    • Dallas, Texas, United States, 75231
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    • Houston, Texas, United States, 77074
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  • Washington
    • Everett, Washington, United States, 98201
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety measures	Treatment Emergent Adverse Events	6 weeks
The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)	change from baseline	6 weeks
The Social Cognition domain of the MCCB	change from baseline	6 weeks

Collaborators and Investigators

• Sponsor: Recognify Life Sciences
• Investigators: Study Director: Gary Walker, PhD, Recognify Life Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2022
• Primary Completion (Actual): April 9, 2025
• Study Completion (Actual): April 9, 2025

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Schizophrenia; Cognitive Dysfunction
• Other Study ID Numbers: C07-03-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No