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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05686239
Other study ID # C07-03-02
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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