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RL-007 for Cognitive Impairment in Schizophrenia
Verified Trial
Tampa, FL
Phase 2
Recruiting
Research Sponsored by Recognify Life Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Do you have problems concentrating or remembering things?
Are you on a stable does of Antipsychotic medication?
Must not have
Have you been diagnosed with Bipolar Disorder?
Are you currently taking *2 or more* different antipsychotic medications?
Timeline
Screening 1 month
Treatment 6 weeks
Follow Up 2 weeks
Summary
This trial is testing a new drug, RL-007, to see if it can help people with schizophrenia think and remember better. The study will compare different doses of the drug and check for any side effects. Participants will take the drug for several weeks and complete memory and thinking tests before and after the treatment.
Who is the study for?
This trial is for adults with schizophrenia who are stable on certain antipsychotic medications, have a BMI of 40 or less, and are not expected to change housing or experience major life events during the study. They should not have been hospitalized recently for medical or psychiatric reasons, have no other major mental health diagnoses, significant brain injuries, severe substance abuse issues in the last six months, nor pose a risk of harm to themselves or others.
What is being tested?
The trial tests if RL-007 can improve cognitive abilities in people with schizophrenia. Participants will either receive RL-007 at doses of 20 mg or 40 mg, or a placebo over six weeks. Their cognitive performance before and after treatment will be compared to see if there's an improvement.
What are the potential side effects?
While specific side effects aren't listed here, safety measures like blood pressure checks, physical exams and ECGs suggest that potential side effects could include changes in heart rhythm, blood pressure variations and general discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowExclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Timeline
Screening ~ 1 month1 visit
Treatment ~ 6 weeks3 visits
Follow Up ~ 2 weeks0 visits
Screening ~ 1 month
Treatment ~ 6 weeks
Follow Up ~2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite
Secondary study objectives
Clinical Global Impression - Severity (CGI-S)
Symbol Coding
The Attention/Vigilance domain of the MCCB
+5 moreOther study objectives
Safety measures
The Social Cognition domain of the MCCB
The Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: RL-007 40 mgExperimental Treatment1 Intervention
oral dosing three times per day (TID)
Group II: RL-007 20 mgExperimental Treatment1 Intervention
oral dosing three times per day (TID)
Group III: PlaceboPlacebo Group1 Intervention
oral dosing three times per day (TID)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RL-007
2021
Completed Phase 2
~40
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for cognitive impairment, particularly those aimed at cognitive enhancement, often involve the modulation of neurotransmitter systems. For example, N-methyl-D-aspartate (NMDA) receptor enhancers work by improving synaptic plasticity and cognitive function through the regulation of glutamate, a key neurotransmitter involved in learning and memory.
Cholinesterase inhibitors, another common treatment, increase the levels of acetylcholine in the brain, which is crucial for memory and attention. These mechanisms are important for cognitive impairment patients as they directly target the neural pathways involved in cognitive processes, potentially improving their cognitive performance and quality of life.
The investigational drug RL-007, being studied for its effects on cognitive impairment associated with schizophrenia, likely operates through similar pathways to enhance cognitive function, making it a promising candidate for improving cognitive outcomes in these patients.
Effect of N-methyl-D-aspartate receptor enhancing agents on cognition in dementia: an exploratory systematic review and meta-analysis of randomized controlled trials.Observations and suggestions on antidementia drug development.Individual goal-oriented cognitive rehabilitation to improve everyday functioning for people with early-stage dementia: A multicentre randomised controlled trial (the GREAT trial).
Effect of N-methyl-D-aspartate receptor enhancing agents on cognition in dementia: an exploratory systematic review and meta-analysis of randomized controlled trials.Observations and suggestions on antidementia drug development.Individual goal-oriented cognitive rehabilitation to improve everyday functioning for people with early-stage dementia: A multicentre randomised controlled trial (the GREAT trial).
Find a Location
Closest Location:Stedman Clinical Trials· Tampa, FL
Who is running the clinical trial?
Recognify Life SciencesLead Sponsor
1 Previous Clinical Trials
37 Total Patients Enrolled
1 Trials studying Schizophrenia
37 Patients Enrolled for Schizophrenia
Gary Walker, PhDStudy DirectorRecognify Life Sciences
1 Previous Clinical Trials
11 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with schizophrenia for at least 6 months.You have a score on a scale of 1 to 10 that shows your symptoms are not very severe.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: RL-007 20 mg
- Group 3: RL-007 40 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Months to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 6 Weeks
- Follow Ups: You may be asked to continue sharing information regarding the trial for 2 Weeks after you stop receiving the treatment.