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Study identifier: NCT05686239 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: Completed

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

Condition: Cognitive Impairment Associated With Schizophrenia (CIAS) · Cognitive Impairment · Schizophrenia  ·  Sponsor: Recognify Life Sciences

PhasePhase 2
Planned participants242
Who can joinAll sexes, 18 Years to 55 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where36 locations · 4 countries
For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.Open the site landscape →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (36)

Recognify Research SiteCulver City, California, United States
Collaborative Neuroscience ResearchGarden Grove, California, United States
Recognify Research SiteLafayette, California, United States
Recognify Research SiteOceanside, California, United States
Recognify Research SiteOrange, California, United States
Recognify Research SiteTorrance, California, United States
Recognify Research SiteHialeah, Florida, United States
Recognify Research SiteMiami, Florida, United States
Recognify Research SiteMiami Lakes, Florida, United States
Recognify Research SiteAtlanta, Georgia, United States
Recognify Research SiteAugusta, Georgia, United States
Recognify Research SiteGaithersburg, Maryland, United States

+ 24 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

Culver CityGarden GroveLafayetteOceanside

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