Cognitive Impairment Associated With Schizophrenia (CIAS)Phase 2NCT05686239
A Study to Evaluate RL-007 in the Treatment of Cognitive Impairment Associated With Schizophrenia (CIAS)
A Phase 2 study testing RL-007 (Inidascamine) in people with Cognitive Impairment Associated With Schizophrenia (CIAS) and Cognitive Impairment, run by Recognify Life Sciences at 36 sites in 4 countries.
Trial 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: 1. Does RL-007 improve subjects performance in a set of cognitive tasks? 2. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Cognitive Impairment Associated With Schizophrenia (CIAS), Cognitive Impairment, Schizophrenia
- What is being tested?
- RL-007 (Inidascamine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 36 sitesin 4 countries
- Study dates
- 8 Dec 2022to 9 Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
United States20 sites
Recognify Research Site
Atlanta, Georgia, 30030
Recognify Research Site
Augusta, Georgia, 30912
Recognify Research Site
Berlin, New Jersey, 08009
Recognify Research Site
Brooklyn, New York, 11235
Recognify Research Site
Chapel Hill, North Carolina, 27599
Recognify Research Site
Cincinnati, Ohio, 45219
Recognify Research Site
Cleveland, Ohio, 44122
Recognify Research Site
Culver City, California, 90230
Recognify Research Site
Dallas, Texas, 75231
Recognify Research Site
Everett, Washington, 98201
Recognify Research Site
Gaithersburg, Maryland, 20877
Collaborative Neuroscience Research
Garden Grove, California, 92845
Recognify Research Site
Hialeah, Florida, 33016
Recognify Research Site
Houston, Texas, 77074
Recognify Research Site
Lafayette, California, 94549
Recognify Research Site
Miami, Florida, 33135
Recognify Research Site
Miami Lakes, Florida, 33016
Recognify Research Site
Oceanside, California, 92056
Recognify Research Site
Orange, California, 92868
Recognify Research Site
Torrance, California, 90502
Bulgaria7 sites
Recognify Research Site
Burgas
Recognify Research Site
Kardzhali
Recognify Research Site
Pleven
Recognify Research Site
Plovdiv
Recognify Research Site
Sofia
Recognify Research Site (a)
Varna
Recognify Research Site (b)
Varna
Poland6 sites
Recognify Research Site
Gdansk
Recognify Research Site
Gorlice
Recognify Research Site
Kielce
Recognify Research Site
Lodz
Recognify Research Site
Lublin
Recognify Research Site
Poznan
Czechia3 sites
Recognify Research Site
Pilsen
Recognify Research Site (a)
Prague
Recognify Research Site (b)
Prague
About this study
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)
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?
Read more
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.
Read the 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
- Cognitive Impairment Associated With Schizophrenia (CIAS), Cognitive Impairment, Schizophrenia
- Being tested
- RL-007 (Inidascamine), Placebo
- Medical subject headings
- Cognitive Dysfunction, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RL-007 (Inidascamine)Drug
investigational study drug
PlaceboDrug
placebo capsules matching the appearance and size of the active drug
| Study group | Role | What they receive |
|---|---|---|
| RL-007 20 mg (Inidascamine) | Experimental | oral dosing three times per day (TID) Receives: Drug: RL-007 (Inidascamine) |
| RL-007 40 mg (Inidascamine) | Experimental | oral dosing three times per day (TID) Receives: Drug: RL-007 (Inidascamine) |
| Placebo | Placebo comparator | oral dosing three times per day (TID) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite
change from baseline in composite of nine cognitive tests
Measured: 6 weeks
Secondary outcomes (8)
Symbol Coding
change from baseline
Measured: 6 weeks
The Speed of Processing domain of the MCCB
change from baseline
Measured: 6 weeks
The Attention/Vigilance domain of the MCCB
change from baseline
Measured: 6 weeks
The Working Memory domain of the MCCB
change from baseline
Measured: 6 weeks
The Verbal Memory domain of the MCCB
change from baseline
Measured: 6 weeks
The Visual Learning domain of the MCCB
change from baseline
Measured: 6 weeks
The Reasoning and Problem-solving domain of the MCCB
change from baseline
Measured: 6 weeks
Clinical Global Impression - Severity (CGI-S)
change from baseline
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start8 Dec 2022
- Primary completion9 Apr 2025
- Study completion9 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment Associated With Schizophrenia (CIAS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recognify Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Walker, PhD, Study director, Recognify Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05686239
- Sponsor's protocol ID
- C07-03-02
- Status last verified
- Jul 2025
- First submitted
- 28 Dec 2022
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05686239
- Acronym / sponsor ID
- C07-03-02
- Conditions
- Cognitive Impairment Associated With Schizophrenia (CIAS), Cognitive Impairment, Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Recognify Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- 9 Apr 2025 (actual)
- Study completion
- 9 Apr 2025 (actual)
- First posted
- 17 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RL-007 20 mg (Inidascamine) | Experimental | Drug: RL-007 (Inidascamine)oral dosing three times per day (TID) |
| RL-007 40 mg (Inidascamine) | Experimental | Drug: RL-007 (Inidascamine)oral dosing three times per day (TID) |
| Placebo | Placebo comparator | Drug: Placebooral dosing three times per day (TID) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RL-007 (Inidascamine)investigational study drug | Drug | RL-007 20 mg (Inidascamine), RL-007 40 mg (Inidascamine) |
| Placeboplacebo capsules matching the appearance and size of the active drug | Drug | Placebo |
Primary outcome
MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite
Time frame: 6 weeks
change from baseline in composite of nine cognitive tests
8 secondary outcomes
Symbol Coding
Time frame: 6 weeks
The Speed of Processing domain of the MCCB
Time frame: 6 weeks
The Attention/Vigilance domain of the MCCB
Time frame: 6 weeks
The Working Memory domain of the MCCB
Time frame: 6 weeks
The Verbal Memory domain of the MCCB
Time frame: 6 weeks
The Visual Learning domain of the MCCB
Time frame: 6 weeks
The Reasoning and Problem-solving domain of the MCCB
Time frame: 6 weeks
Clinical Global Impression - Severity (CGI-S)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Walker, PhD study director
Recognify Life Sciences
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RL-007 (Inidascamine) in people with Cognitive Impairment Associated With Schizophrenia (CIAS) and Cognitive Impairment, run by Recognify Life Sciences at 36 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, Bulgaria, Poland, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MATRICS Consensus Cognitive Battery (MCCB) neurocognitive composite (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.