Clinical trial NCT05686239: A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cognitive Impairment Associated With Schizophrenia (CIAS)
Cognitive Impairment
Schizophrenia
Lead sponsor: Recognify Life Sciences
Sponsor class: INDUSTRY
First posted: 2023-01-17
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

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.

Eligibility 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.

Primary outcomes:
measure: MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite
timeFrame: 6 weeks
Secondary outcomes:
measure: Symbol Coding
timeFrame: 6 weeks
measure: The Speed of Processing domain of the MCCB
timeFrame: 6 weeks
measure: The Attention/Vigilance domain of the MCCB
timeFrame: 6 weeks
measure: The Working Memory domain of the MCCB
timeFrame: 6 weeks
measure: The Verbal Memory domain of the MCCB
timeFrame: 6 weeks
measure: The Visual Learning domain of the MCCB
timeFrame: 6 weeks
measure: The Reasoning and Problem-solving domain of the MCCB
timeFrame: 6 weeks
measure: Clinical Global Impression - Severity (CGI-S)
timeFrame: 6 weeks
Other outcomes:
measure: Safety measures
timeFrame: 6 weeks
measure: The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
timeFrame: 6 weeks
measure: The Social Cognition domain of the MCCB
timeFrame: 6 weeks
Locations:
city: Culver City
country: United States
facility: Recognify Research Site
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Research
state: California
city: Lafayette
country: United States
facility: Recognify Research Site
state: California
city: Oceanside
country: United States
facility: Recognify Research Site
state: California
city: Orange
country: United States
facility: Recognify Research Site
state: California
city: Torrance
country: United States
facility: Recognify Research Site
state: California
city: Clermont
country: United States
facility: Recognify Research Site
state: Florida
city: Hialeah
country: United States
facility: Recognify Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Recognify Research Site
state: Florida
city: Miami
country: United States
facility: Recognify Research Site
state: Florida
city: Atlanta
country: United States
facility: Recognify Research Site
state: Georgia
city: Augusta
country: United States
facility: Recognify Research Site
state: Georgia
city: Gaithersburg
country: United States
facility: Recognify Research Site
state: Maryland
city: Berlin
country: United States
facility: Recognify Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Recognify Research Site
state: New York
city: Chapel Hill
country: United States
facility: Recognify Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Recognify Research Site
state: Ohio
city: Cleveland
country: United States
facility: Recognify Research Site
state: Ohio
city: Dallas
country: United States
facility: Recognify Research Site
state: Texas
city: Houston
country: United States
facility: Recognify Research Site
state: Texas
city: Everett
country: United States
facility: Recognify Research Site
state: Washington
city: Sofia
country: Bulgaria
facility: Recognify Research Site
city: Plzen
country: Czechia
facility: Recognify Research Site
city: Gdansk
country: Poland
facility: Recognify Research Site
Study officials:
affiliation: Recognify Life Sciences
name: Gary Walker, PhD
role: STUDY_DIRECTOR
References: