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

Primary Purpose

Cognitive Impairment Associated With Schizophrenia (CIAS), Cognitive Impairment, Schizophrenia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RL-007
Placebo
Sponsored by
Recognify Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment Associated With Schizophrenia (CIAS)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Recognify Research SiteRecruiting
  • Collaborative Neuroscience ResearchRecruiting
  • Recognify Research SiteRecruiting
  • 125 Clairemont AvenueRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • 125 Clairemont AvenueRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • 125 Clairemont AvenueRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • Recognify Research SiteRecruiting
  • 125 Clairemont AvenueRecruiting
  • Recognify Research SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

RL-007 20 mg

RL-007 40 mg

Placebo

Arm Description

oral dosing three times per day (TID)

oral dosing three times per day (TID)

oral dosing three times per day (TID)

Outcomes

Primary Outcome Measures

MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite
change from baseline in composite of nine cognitive tests

Secondary Outcome Measures

Symbol Coding
change from baseline
The Speed of Processing domain of the MCCB
change from baseline
The Attention/Vigilance domain of the MCCB
change from baseline
The Working Memory domain of the MCCB
change from baseline
The Verbal Memory domain of the MCCB
change from baseline
The Visual Learning domain of the MCCB
change from baseline
The Reasoning and Problem-solving domain of the MCCB
change from baseline
Clinical Global Impression - Severity (CGI-S)
change from baseline

Full Information

First Posted
December 28, 2022
Last Updated
August 23, 2023
Sponsor
Recognify Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05686239
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Recognify Life Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment Associated With Schizophrenia (CIAS), Cognitive Impairment, Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
234 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RL-007 20 mg
Arm Type
Experimental
Arm Description
oral dosing three times per day (TID)
Arm Title
RL-007 40 mg
Arm Type
Experimental
Arm Description
oral dosing three times per day (TID)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral dosing three times per day (TID)
Intervention Type
Drug
Intervention Name(s)
RL-007
Intervention Description
investigational study drug
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo capsules matching the appearance and size of the active drug
Primary Outcome Measure Information:
Title
MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite
Description
change from baseline in composite of nine cognitive tests
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Symbol Coding
Description
change from baseline
Time Frame
6 weeks
Title
The Speed of Processing domain of the MCCB
Description
change from baseline
Time Frame
6 weeks
Title
The Attention/Vigilance domain of the MCCB
Description
change from baseline
Time Frame
6 weeks
Title
The Working Memory domain of the MCCB
Description
change from baseline
Time Frame
6 weeks
Title
The Verbal Memory domain of the MCCB
Description
change from baseline
Time Frame
6 weeks
Title
The Visual Learning domain of the MCCB
Description
change from baseline
Time Frame
6 weeks
Title
The Reasoning and Problem-solving domain of the MCCB
Description
change from baseline
Time Frame
6 weeks
Title
Clinical Global Impression - Severity (CGI-S)
Description
change from baseline
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Safety measures
Description
Treatment Emergent Adverse Events
Time Frame
6 weeks
Title
The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Description
change from baseline
Time Frame
6 weeks
Title
The Social Cognition domain of the MCCB
Description
change from baseline
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gary Walker, PhD
Phone
510-552-0136
Email
cias2@recognify.life
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Pando, PhD
Phone
571-217-1255
Email
cias2@recognify.life
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Walker, PhD
Organizational Affiliation
Recognify Life Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Recognify Research Site
City
Culver City
State/Province
California
ZIP/Postal Code
90230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Collaborative Neuroscience Research
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Walling, PhD
Phone
714-799-7799
First Name & Middle Initial & Last Name & Degree
David Walling, PhD
Facility Name
Recognify Research Site
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
125 Clairemont Avenue
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
125 Clairemont Avenue
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Gaithersburg
State/Province
Maryland
ZIP/Postal Code
20877
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
125 Clairemont Avenue
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
125 Clairemont Avenue
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI
Facility Name
Recognify Research Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PI

12. IPD Sharing Statement

Plan to Share IPD
No

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

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