← Back to Search

Other

RL-007 for Cognitive Impairment in Schizophrenia

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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will assess if RL-007 can improve cognitive performance in people with schizophrenia. Subjects will take a placebo or RL-007 & do cognitive tests before & after to compare results. Safety measures will be taken throughout.

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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite
Secondary outcome measures
Clinical Global Impression - Severity (CGI-S)
Symbol Coding
The Attention/Vigilance domain of the MCCB
+5 more
Other outcome measures
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

Find a Location

Who is running the clinical trial?

Recognify Life SciencesLead Sponsor
1 Previous Clinical Trials
37 Total Patients Enrolled
Gary Walker, PhDStudy DirectorRecognify Life Sciences
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

RL-007 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05686239 — Phase 2
Cognitive Impairment Research Study Groups: Placebo, RL-007 20 mg, RL-007 40 mg
Cognitive Impairment Clinical Trial 2023: RL-007 Highlights & Side Effects. Trial Name: NCT05686239 — Phase 2
RL-007 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05686239 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are minors permitted to participate in this research?

"The age range for study participants is 18 to 55. For those below that threshold, there are 67 trials available and 711 above the 65 year old mark."

Answered by AI

Is the 20 mg dosage of RL-007 officially sanctioned by the FDA?

"Although there is some evidence of RL-007 20 mg's safety, as this is a Phase 2 study with no data regarding efficacy, it has been assigned an estimation score of 2."

Answered by AI

Am I eligible to join this clinical research project?

"This clinical trial is searching for 234 people aged between 18 and 55, diagnosed with schizophrenia-induced cognitive impairment. Additionally, these participants must have a PANSS score of no more than 80 points; be taking a single atypical antipsychotic (bar clozapine); present clinically stable results over the past 6 weeks before randomization; demonstrate a Clinical Global Impression - Severity lower than 5.; Body Mass Index not exceeding 40 kg/m^2; possess secure housing which will remain unchanged during the study period alongside no foreseen life changes that may impact its outcomes; exhibit adequate fluency in English to comprehend and complete assessments"

Answered by AI

Are there any open opportunities to join this research initiative?

"Affirmative, the information accessible on clinicaltrials.gov confirms this trial is currently enrolling patients. It was initially posted on December 8th 2022 and last updated January 8th 2023 with a goal of recruiting 234 individuals at one site."

Answered by AI

What is the total number of participants currently taking part in this experiment?

"Affirmative. Clinicaltrials.gov states that recruitment for this clinical trial is still active, having first been advertised on December 8th 2022 and most recently edited on January 8th 2023. The study requires the enrollment of 234 patients at a single site."

Answered by AI

Who else is applying?

What state do they live in?
New York
What site did they apply to?
Recognify Research Site
Other
125 Clairemont Avenue
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+

Why did patients apply to this trial?

I've done other studies that did not work. I would like to understand my condition better.
PatientReceived 1 prior treatment
Looking for a study that might help the medication I’m using.
PatientReceived 2+ prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Average response time
  • < 2 Days
Most responsive sites:
  1. Recognify Research Site: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
2022. "A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05686239.
~25 spots leftby Jul 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top