A Single-arm, Single-blind, Multiple Dose Study to Evaluate Safety and the Effects of RL-007 on Electroencephalograms and Event-related Potentials in Subjects With Schizophrenia

Recognify Life Sciences1 site in 1 country37 target enrollmentApril 26, 2021

ConditionsCognitive Impairment Schizophrenia

InterventionsRL-007 RL-007 Matching Placebo

DrugsRL-007 RL-007 Matching Placebo

Overview

Phase: Phase 2
Intervention: RL-007
Conditions: Cognitive Impairment
Sponsor: Recognify Life Sciences
Enrollment: 37
Locations: 1
Primary Endpoint: Incidence of Treatment-emergent Adverse Events (TEAE)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia

Detailed Description

Potential participants will first be given an Informed Consent document and have the study explained to them. All patients who provide written informed consent will undergo screening to determine eligibility for the study. Patients who meet all eligibility criteria will be admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants will be assigned to a specific dose cohort and will receive sequence that includes both placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2 and 4.

Registry

clinicaltrials.gov

Start Date

April 26, 2021

End Date

October 28, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Recognify Life Sciences

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide a written informed consent
•Diagnosis of schizophrenia, as defined by DSM-5 and evaluated with the MINI Plus interview
•Positive and Negative Symptoms Severity Score (PANSS) of 40 - 80 (inclusive), and a score of 4 or less on the following PANSS items: P2, P3, P5, P6, G
•Currently being treated with a single protocol-allowed antipsychotic at a stable dose and clinically stable for at least 8 weeks before admission (note: allowed meds = aripiprazole, brexipiprazole, paliperidone, risperidone)
•Modified Simpson-Angus Scale total score \<= 4
•At least 1 standard deviation below normative value of total number of words recalled on the Hopkins Verbal Learning Test
•BMI \<= 38

Exclusion Criteria

•History of hospitalization for medical indication within 4 weeks prior to screening or psychiatric hospitalization within 3 months prior to screening
•Use of any other psychoactive medication known to interfere with the EEG/ERP assessments within 1 week prior to screening or during the study period.
•Subjects who present a serious risk of suicide
•Any history of GI surgery, or other condition, that may affect GI absorption or any history of GI bleeding or peptic ulcer.
•Evidence or history of significant cognitive impairment, other than associated with schizophrenia, that in the judgement of the Investigator would confound secondary or exploratory assessments or prevent safe and satisfactory completion of the study protocol.
•Moderate to severe alcohol use disorder, per DSM-5 within 3 months of admission visit.
•Positive alcohol breath test or urine test for drugs of abuse at either screening or admission visit.
•Currently smoking more than 1 pack of cigarettes a day and unable or unwilling to maintain smoking to less than 1 pack a day during in-patient portion of study.
•Positive test result for SARS-CoV2 prior to admission per site standards.
•Positive test for hepatitis B, hepatitis C or HIV

Arms & Interventions

Dose-escalation - RL-007

Each cohort will include a single dose-strength. Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant.

Intervention: RL-007