History of Changes for Study: NCT05686239

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

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Study Record Versions

Version	A	B	Submitted Date	Changes
1			January 8, 2023	None (earliest Version on record)
2			August 23, 2023	Study Status and Contacts/Locations

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	C07-03-02
Brief Title:	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)
Secondary IDs:

Study Status


Record Verification:	January 2023
Overall Status:	Recruiting
Study Start:	December 8, 2022
Primary Completion:	July 15, 2024 [Anticipated]
Study Completion:	November 15, 2024 [Anticipated]

First Submitted:	December 28, 2022
First Submitted that Met QC Criteria:	January 8, 2023
First Posted:	January 17, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	January 8, 2023
Last Update Posted:	January 17, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Recognify Life Sciences
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	Yes
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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:

Does RL-007 improve subjects performance in a set of cognitive tasks?
Which dose of RL-007 (20 mg or 40 mg) has a larger effect on cognitive performance?
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.

Conditions


Conditions:	Cognitive Impairment Associated With Schizophrenia (CIAS) Cognitive Impairment Schizophrenia
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2
Interventional Study Model:	Parallel Assignment
Number of Arms:	3
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized
Enrollment:	234 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: RL-007 20 mg oral dosing three times per day (TID)	Drug: RL-007 investigational study drug
Experimental: RL-007 40 mg oral dosing three times per day (TID)	Drug: RL-007 investigational study drug
Placebo Comparator: Placebo oral dosing three times per day (TID)	Drug: Placebo placebo capsules matching the appearance and size of the active drug

Outcome Measures


Primary Outcome Measures:
1.	MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite [ Time Frame: 6 weeks ] change from baseline in composite of nine cognitive tests
Secondary Outcome Measures:
1.	Symbol Coding [ Time Frame: 6 weeks ] change from baseline
2.	The Speed of Processing domain of the MCCB [ Time Frame: 6 weeks ] change from baseline
3.	The Attention/Vigilance domain of the MCCB [ Time Frame: 6 weeks ] change from baseline
4.	The Working Memory domain of the MCCB [ Time Frame: 6 weeks ] change from baseline
5.	The Verbal Memory domain of the MCCB [ Time Frame: 6 weeks ] change from baseline
6.	The Visual Learning domain of the MCCB [ Time Frame: 6 weeks ] change from baseline
7.	The Reasoning and Problem-solving domain of the MCCB [ Time Frame: 6 weeks ] change from baseline
8.	Clinical Global Impression - Severity (CGI-S) [ Time Frame: 6 weeks ] change from baseline
Other Outcome Measures:
1.	Safety measures [ Time Frame: 6 weeks ] Treatment Emergent Adverse Events
2.	The Virtual Reality Functional Capacity Assessment Tool (VRFCAT) [ Time Frame: 6 weeks ] change from baseline
3.	The Social Cognition domain of the MCCB [ Time Frame: 6 weeks ] change from baseline

Eligibility


Minimum Age:	18 Years
Maximum Age:	55 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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.

Contacts/Locations


Central Contact Person:	Gary Walker, PhD Telephone: 510-552-0136 Email: cias2@recognify.life
Central Contact Backup:	Matt Pando, PhD Telephone: 571-217-1255 Email: cias2@recognify.life
Study Officials:	Gary Walker, PhD Study Director Recognify Life Sciences
Locations:	United States, California
	Collaborative Neuroscience Research [Recruiting] Garden Grove, California, United States, 92845 Contact:Contact: David Walling, PhD 714-799-7799 Contact:Principal Investigator: David Walling, PhD

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: