Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia

Phase 2

Completed

• Conditions: Cognitive Impairment; Schizophrenia
• Interventions: Drug: RL-007; Drug: RL-007 Matching Placebo

• Registration Number: NCT04822883
• Lead Sponsor: Recognify Life Sciences

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.

Study Timeline

• Study First Submitted: 2021-03-12
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Study Start: 2021-04-26
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-25
• Last Update Posted: 2022-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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, G6.
• 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

Key

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
• Subjects whose hair type or style is likely to interfere with successful application of scalp electrodes.
• Subjects with needle phobia or in whom venous access is technically difficult.
• Other unspecified reasons that, in the opinion of the PI or sponsor, make the subject unsuitable for enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose-escalation - RL-007	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.
Dose-escalation - matching Placebo	RL-007 Matching Placebo	Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Adverse Events (TEAE)	Study Day 8.	Comparison of AE rates between active and placebo dosing
Change in heart rate from baseline	Study Day 4	heart rate measured in beats per minute; baseline = Day -1
Change in respiratory rate from baseline	Study Day 4	respiratory rate measured in breaths per minute; baseline = Day -1
Change in temperature from baseline	Study Day 4	temperature measured in degrees Celsius; baseline = Day -1
Change in electrocardiogram (ECG) from baseline	Study Day 3	overall physician interpretation of ECG reading; baseline = Day -1
Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline	Study Day 8	The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1
Change in blood pressure (systolic and diastolic) from baseline	Study Day 4	blood pressure measured in mmHg; baseline = Day -1

Secondary Outcome Measures

Name	Time	Method
Change from baseline in quantitative electroencephalogram (qEEG)	Study Day 4	change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma)
Change from baseline in evoked response potential (ERP) amplitude	Study Day 4	Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP
Change from baseline in evoked response potential (ERP) latency	Study Day 4	Change from baseline in signal latency of the two-stimulus auditory oddball ERP
Change from baseline in amplitude of mismatch negativity (MMN) ERP	Study Day 4	Change from baseline in signal amplitude of the MMN ERP
Change from baseline in latency of mismatch negativity (MMN) ERP	Study Day 4	Change from baseline in signal latency of the MMN ERP

Trial Locations

Locations (1)

Collaborative Neuroscience Research; 🇺🇸 Long Beach, California, United States