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Evaluating RL-007 for cognitive impairment in schizophrenia

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)

Phase 2 Interventional Recognify Life Sciences · NCT05686239

This study is testing a new drug called RL-007 to see if it can help people with schizophrenia improve their thinking skills over six weeks.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment234 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorRecognify Life Sciences Industry-sponsored
Locations24 sites (Culver City, California and 23 other locations)
Trial IDNCT05686239 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of the investigational drug RL-007 in improving cognitive performance in individuals diagnosed with schizophrenia. Participants will undergo cognitive tasks before and after a 6-week treatment period during which they will receive either RL-007 or a placebo. The study will also evaluate the tolerability of RL-007 and compare the effects of two different doses (20 mg and 40 mg) on cognitive performance. Safety measures will be monitored throughout the trial to identify any potential side effects.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with schizophrenia for at least 6 months who are stable on a single atypical antipsychotic medication.

Not a fit: Patients with a recent history of psychiatric hospitalization or those at serious risk of suicide may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance cognitive functioning in patients with schizophrenia, potentially improving their overall quality of life.

How similar studies have performed: While this approach is novel in its specific application, similar studies targeting cognitive impairment in schizophrenia have shown promising results.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Culver City, California and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Cognitive Impairment Associated With SchizophreniaCognitive ImpairmentSchizophrenia
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.