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

NCT05686239 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: C07-03-02
• Study Type: interventional
• Target: 242
• Locations: 4 countries
• Sites: 36

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. 1.Does RL-007 improve subjects performance in a set of cognitive tasks?
2. 2.Which dose of RL-007 (20 mg or 40 mg) has a larger effect on cognitive performance?
3. 3.How well do subjects tolerate RL-007?

Conditions

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

Outcome Measures

Primary Outcomes (1)

• MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite

  change from baseline in composite of nine cognitive tests

  6 weeks

Secondary Outcomes (8)

• Symbol Coding

  6 weeks

• The Speed of Processing domain of the MCCB

  6 weeks

• The Attention/Vigilance domain of the MCCB

  6 weeks

• The Working Memory domain of the MCCB

  6 weeks

• The Verbal Memory domain of the MCCB

  6 weeks

Other Outcomes (3)

• Safety measures

  6 weeks

• The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)

  6 weeks

• The Social Cognition domain of the MCCB

  6 weeks

Study Arms (3)

RL-007 20 mg (Inidascamine)

EXPERIMENTAL

oral dosing three times per day (TID)

Drug: RL-007 (Inidascamine)

RL-007 40 mg (Inidascamine)

EXPERIMENTAL

oral dosing three times per day (TID)

Drug: RL-007 (Inidascamine)

Placebo

PLACEBO COMPARATOR

oral dosing three times per day (TID)

Drug: Placebo

Interventions

RL-007 (Inidascamine) DRUG

investigational study drug

RL-007 20 mg (Inidascamine); RL-007 40 mg (Inidascamine)

Placebo DRUG

placebo capsules matching the appearance and size of the active drug

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Recognify Life Sciences: lead

Study Sites (36)

Recognify Research Site

Culver City, California, 90230, United States

Location

Collaborative Neuroscience Research

Garden Grove, California, 92845, United States

Location

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Lafayette, California, 94549, United States

Location

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Oceanside, California, 92056, United States

Location

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Orange, California, 92868, United States

Location

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Torrance, California, 90502, United States

Location

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Hialeah, Florida, 33016, United States

Location

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Miami, Florida, 33135, United States

Location

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Miami Lakes, Florida, 33016, United States

Location

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Atlanta, Georgia, 30030, United States

Location

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Augusta, Georgia, 30912, United States

Location

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Gaithersburg, Maryland, 20877, United States

Location

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Berlin, New Jersey, 08009, United States

Location

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Brooklyn, New York, 11235, United States

Location

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Chapel Hill, North Carolina, 27599, United States

Location

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Cincinnati, Ohio, 45219, United States

Location

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Cleveland, Ohio, 44122, United States

Location

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Dallas, Texas, 75231, United States

Location

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Houston, Texas, 77074, United States

Location

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Everett, Washington, 98201, United States

Location

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Burgas, Bulgaria

Location

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Kardzhali, Bulgaria

Location

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Pleven, Bulgaria

Location

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Plovdiv, Bulgaria

Location

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Sofia, Bulgaria

Location

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Varna, Bulgaria

Location

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Varna, Bulgaria

Location

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Pilsen, Czechia

Location

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Prague, Czechia

Location

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Prague, Czechia

Location

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Gdansk, Poland

Location

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Gorlice, Poland

Location

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Kielce, Poland

Location

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Lodz, Poland

Location

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Lublin, Poland

Location

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Poznan, Poland

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Schizophrenia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

• Gary Walker, PhD

  Recognify Life Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 17, 2023
• Study Start: December 8, 2022
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (20); PL (6); CZ (3); BU (7)