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

Schizophrenia Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05686239
• Other study ID #: C07-03-02
• Status: Recruiting
• Phase: Phase 2
• Start date: December 8, 2022
• Est. completion date: November 15, 2024

Study information

• Verified date: August 2023
• Source: Recognify Life Sciences
• Contact: Gary Walker, PhD
• Phone: 510-552-0136
• Email: cias2[@]recognify.life
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: November 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Cognitive Impairment Associated With Schizophrenia (CIAS)
• Schizophrenia

Intervention

Drug:
• RL-007
investigational study drug
• Placebo
placebo capsules matching the appearance and size of the active drug

Locations

Country	Name	City	State
United States	Recognify Research Site	Atlanta	Georgia
United States	Recognify Research Site	Augusta	Georgia
United States	Recognify Research Site	Berlin	New Jersey
United States	125 Clairemont Avenue	Brooklyn	New York
United States	Recognify Research Site	Chapel Hill	North Carolina
United States	Recognify Research Site	Cincinnati	Ohio
United States	Recognify Research Site	Clermont	Florida
United States	Recognify Research Site	Cleveland	Ohio
United States	Recognify Research Site	Culver City	California
United States	Recognify Research Site	Dallas	Texas
United States	Recognify Research Site	Everett	Washington
United States	Recognify Research Site	Gaithersburg	Maryland
United States	Collaborative Neuroscience Research	Garden Grove	California
United States	Recognify Research Site	Hialeah	Florida
United States	125 Clairemont Avenue	Houston	Texas
United States	Recognify Research Site	Lafayette	California
United States	125 Clairemont Avenue	Miami	Florida
United States	Recognify Research Site	Miami Lakes	Florida
United States	125 Clairemont Avenue	Oceanside	California
United States	Recognify Research Site	Orange	California
United States	Recognify Research Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Recognify Life Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety measures	Treatment Emergent Adverse Events	6 weeks
Other	The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)	change from baseline	6 weeks
Other	The Social Cognition domain of the MCCB	change from baseline	6 weeks
Primary	MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite	change from baseline in composite of nine cognitive tests	6 weeks
Secondary	Symbol Coding	change from baseline	6 weeks
Secondary	The Speed of Processing domain of the MCCB	change from baseline	6 weeks
Secondary	The Attention/Vigilance domain of the MCCB	change from baseline	6 weeks
Secondary	The Working Memory domain of the MCCB	change from baseline	6 weeks
Secondary	The Verbal Memory domain of the MCCB	change from baseline	6 weeks
Secondary	The Visual Learning domain of the MCCB	change from baseline	6 weeks
Secondary	The Reasoning and Problem-solving domain of the MCCB	change from baseline	6 weeks
Secondary	Clinical Global Impression - Severity (CGI-S)	change from baseline	6 weeks