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

Last updated: September 13, 2024
Sponsor: Recognify Life Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Schizotypal Personality Disorder (Spd)

Tourette's Syndrome

Learning Disorders

Treatment

RL-007

Placebo

Clinical Study ID

NCT05686239
C07-03-02
  • Ages 18-55
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Diagnosis of schizophrenia, per Diagnostic and Statistical Manual (DSM) 5, with aduration 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 astable 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 studyperiod with no expected significant life events that could affect study outcomesthroughout entire study period.

  • Sufficient fluency in English to understand and complete study instructions andassessments

Exclusion

Key Exclusion Criteria:

  • History of hospitalization for medical indication or psychiatric hospitalizationwithin 3 months prior to screening.

  • Participants who present a serious risk of suicide, as evidenced by a) "yes" onitems 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) and meetingthese criteria within the past 6 months, or b) posing a significant suicide risk inthe Investigator's judgement.

  • Participants who present a risk of serious harm to others, as evidence by anyhistory within the past 2 years and any expressed homicidal ideation (with orwithout plan).

  • Current diagnosis of another major psychiatric disorder, intellectual disability, orany major neurological disease, brain injury, epilepsy, or severe brain trauma.

  • Evidence or history of significant cognitive impairment, other than associated withschizophrenia, that in the judgement of the Investigator or Sponsor would confoundinterpretation of study data or prevent safe and satisfactory completion of thestudy protocol.

  • Meets criteria for moderate to severe substance/drug abuse disorder (includingalcohol) per DSM-5 within the last 6 months prior to informed consent or a positivealcohol breath test or urine test for drugs of abuse at either Screening orRandomization Visits (except for benzodiazepines taken according to prescription andas an ongoing, stable regimen).

  • Participant has undergone electroconvulsive therapy within the past 12 months.

Study Design

Total Participants: 234
Treatment Group(s): 2
Primary Treatment: RL-007
Phase: 2
Study Start date:
December 08, 2022
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Recognify Research Site

    Sofia,
    Bulgaria

    Active - Recruiting

  • Recognify Research Site

    Plzen,
    Czechia

    Active - Recruiting

  • Recognify Research Site

    Gdansk,
    Poland

    Active - Recruiting

  • Recognify Research Site

    Culver City, California 90230
    United States

    Active - Recruiting

  • Collaborative Neuroscience Research

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • Recognify Research Site

    Lafayette, California 94549
    United States

    Active - Recruiting

  • 125 Clairemont Avenue

    Oceanside, California 92056
    United States

    Site Not Available

  • Recognify Research Site

    Oceanside, California 92056
    United States

    Active - Recruiting

  • Recognify Research Site

    Orange, California 92868
    United States

    Active - Recruiting

  • Recognify Research Site

    Torrance, California 90502
    United States

    Active - Recruiting

  • Recognify Research Site

    Clermont, Florida 34711
    United States

    Site Not Available

  • Recognify Research Site

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • 125 Clairemont Avenue

    Miami, Florida 33135
    United States

    Site Not Available

  • Recognify Research Site

    Miami, Florida 33135
    United States

    Active - Recruiting

  • Recognify Research Site

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Recognify Research Site

    Atlanta, Georgia 30030
    United States

    Active - Recruiting

  • Recognify Research Site

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • Recognify Research Site

    Gaithersburg, Maryland 20877
    United States

    Active - Recruiting

  • Recognify Research Site

    Berlin, New Jersey 08009
    United States

    Active - Recruiting

  • 125 Clairemont Avenue

    Brooklyn, New York 11235
    United States

    Site Not Available

  • Recognify Research Site

    Brooklyn, New York 11235
    United States

    Active - Recruiting

  • Recognify Research Site

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Recognify Research Site

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Recognify Research Site

    Cleveland, Ohio 44122
    United States

    Active - Recruiting

  • Recognify Research Site

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • 125 Clairemont Avenue

    Houston, Texas 77074
    United States

    Site Not Available

  • Recognify Research Site

    Houston, Texas 77074
    United States

    Terminated

  • Recognify Research Site

    Everett, Washington 98201
    United States

    Terminated

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