Cognitive ImpairmentPhase 2NCT04822883
Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia
A Phase 2 study testing RL-007 in people with Cognitive Impairment and Schizophrenia, run by Recognify Life Sciences at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cognitive Impairment, Schizophrenia
- What is being tested?
- RL-007
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2021to 28 Oct 2021
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Provide a written informed consent
- Diagnosis of schizophrenia, as defined by DSM-5 and evaluated with the MINI Plus interview
- Positive and Negative Symptoms Severity Score (PANSS) of 40 - 80 (inclusive), and a score of 4 or less on the following PANSS items: P2, P3, P5, P6, G6.
- Currently being treated with a single protocol-allowed antipsychotic at a stable dose and clinically stable for at least 8 weeks before admission (note: allowed meds = aripiprazole, brexipiprazole, paliperidone, risperidone)
- Modified Simpson-Angus Scale total score <= 4
- At least 1 standard deviation below normative value of total number of words recalled on the Hopkins Verbal Learning Test
- BMI <= 38
Who cannot join
- History of hospitalization for medical indication within 4 weeks prior to screening or psychiatric hospitalization within 3 months prior to screening
- Use of any other psychoactive medication known to interfere with the EEG/ERP assessments within 1 week prior to screening or during the study period.
- Subjects who present a serious risk of suicide
- Any history of GI surgery, or other condition, that may affect GI absorption or any history of GI bleeding or peptic ulcer.
- Evidence or history of significant cognitive impairment, other than associated with schizophrenia, that in the judgement of the Investigator would confound secondary or exploratory assessments or prevent safe and satisfactory completion of the study protocol.
- Moderate to severe alcohol use disorder, per DSM-5 within 3 months of admission visit.
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- Positive alcohol breath test or urine test for drugs of abuse at either screening or admission visit.
- Currently smoking more than 1 pack of cigarettes a day and unable or unwilling to maintain smoking to less than 1 pack a day during in-patient portion of study.
- Positive test result for SARS-CoV2 prior to admission per site standards.
- Positive test for hepatitis B, hepatitis C or HIV
- Subjects whose hair type or style is likely to interfere with successful application of scalp electrodes.
- Subjects with needle phobia or in whom venous access is technically difficult.
- Other unspecified reasons that, in the opinion of the PI or sponsor, make the subject unsuitable for enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Collaborative Neuroscience Research
Long Beach, California, 90806
About this study
Official title: A Single-arm, Single-blind, Multiple Dose Study to Evaluate Safety and the Effects of RL-007 on Electroencephalograms and Event-related Potentials in Subjects With Schizophrenia
The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia
Read the detailed description
Potential participants will first be given an Informed Consent document and have the study explained to them. All patients who provide written informed consent will undergo screening to determine eligibility for the study. Patients who meet all eligibility criteria will be admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants will be assigned to a specific dose cohort and will receive sequence that includes both placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2 and 4.
- Conditions
- Cognitive Impairment, Schizophrenia
- Being tested
- RL-007, RL-007 Matching 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-007Drug
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
RL-007 Matching PlaceboDrug
Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation - RL-007 | Experimental | Each cohort will include a single dose-strength. Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant. Receives: Drug: RL-007 |
| Dose-escalation - matching Placebo | Placebo comparator | Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant. Receives: Drug: RL-007 Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-emergent Adverse Events (TEAE)
Comparison of AE rates between active and placebo dosing
Measured: Study Day 8.
Change in blood pressure (systolic and diastolic) from baseline
blood pressure measured in mmHg; baseline = Day -1
Measured: Study Day 4
Change in heart rate from baseline
heart rate measured in beats per minute; baseline = Day -1
Measured: Study Day 4
Change in respiratory rate from baseline
respiratory rate measured in breaths per minute; baseline = Day -1
Measured: Study Day 4
Change in temperature from baseline
temperature measured in degrees Celsius; baseline = Day -1
Measured: Study Day 4
Change in electrocardiogram (ECG) from baseline
overall physician interpretation of ECG reading; baseline = Day -1
Measured: Study Day 3
Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline
The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1
Measured: Study Day 8
Secondary outcomes (5)
Change from baseline in quantitative electroencephalogram (qEEG)
change from baseline in amplitude across qEEG frequency bands (alpha, beta, delta, theta, and gamma)
Measured: Study Day 4
Change from baseline in evoked response potential (ERP) amplitude
Change from baseline in signal amplitude of the two-stimulus auditory oddball ERP
Measured: Study Day 4
Change from baseline in evoked response potential (ERP) latency
Change from baseline in signal latency of the two-stimulus auditory oddball ERP
Measured: Study Day 4
Change from baseline in amplitude of mismatch negativity (MMN) ERP
Change from baseline in signal amplitude of the MMN ERP
Measured: Study Day 4
Change from baseline in latency of mismatch negativity (MMN) ERP
Change from baseline in signal latency of the MMN ERP
Measured: Study Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start26 Apr 2021
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Four dose cohorts will be enrolled sequentially.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recognify Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Walling, PhD, Principal investigator, Collaborative Neuroscience Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04822883
- Sponsor's protocol ID
- C07-03-01
- Status last verified
- Apr 2022
- First submitted
- 12 Mar 2021
- Last updated
- 27 Apr 2022
- 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-blind, Multiple Dose Study to Evaluate Safety and the Effects of RL-007 on Electroencephalograms and Event-related Potentials in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT04822883
- Acronym / sponsor ID
- C07-03-01
- Conditions
- Cognitive Impairment, Schizophrenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Recognify Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 30 Mar 2021 (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 purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia
Detailed description
Potential participants will first be given an Informed Consent document and have the study explained to them. All patients who provide written informed consent will undergo screening to determine eligibility for the study. Patients who meet all eligibility criteria will be admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants will be assigned to a specific dose cohort and will receive sequence that includes both placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2 and 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Four dose cohorts will be enrolled sequentially.
| Arm | Type | Receives |
|---|---|---|
| Dose-escalation - RL-007 | Experimental | Drug: RL-007Each cohort will include a single dose-strength. Within each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant. |
| Dose-escalation - matching Placebo | Placebo comparator | Drug: RL-007 Matching PlaceboWithin each cohort, the sequence of active capsules and matching placebo capsules will be varied and unknown to the participant. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Provide a written informed consent
- Diagnosis of schizophrenia, as defined by DSM-5 and evaluated with the MINI Plus interview
- Positive and Negative Symptoms Severity Score (PANSS) of 40 - 80 (inclusive), and a score of 4 or less on the following PANSS items: P2, P3, P5, P6, G6.
- Currently being treated with a single protocol-allowed antipsychotic at a stable dose and clinically stable for at least 8 weeks before admission (note: allowed meds = aripiprazole, brexipiprazole, paliperidone, risperidone)
- Modified Simpson-Angus Scale total score <= 4
Key exclusion criteria (13 listed)
- History of hospitalization for medical indication within 4 weeks prior to screening or psychiatric hospitalization within 3 months prior to screening
- Use of any other psychoactive medication known to interfere with the EEG/ERP assessments within 1 week prior to screening or during the study period.
- Subjects who present a serious risk of suicide
- Any history of GI surgery, or other condition, that may affect GI absorption or any history of GI bleeding or peptic ulcer.
- Evidence or history of significant cognitive impairment, other than associated with schizophrenia, that in the judgement of the Investigator would confound secondary or exploratory assessments 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-007Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing | Drug | Dose-escalation - RL-007 |
| RL-007 Matching PlaceboCohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing | Drug | Dose-escalation - matching Placebo |
Primary outcome
Incidence of Treatment-emergent Adverse Events (TEAE)
Time frame: Study Day 8.
Comparison of AE rates between active and placebo dosing
Change in blood pressure (systolic and diastolic) from baseline
Time frame: Study Day 4
blood pressure measured in mmHg; baseline = Day -1
Change in heart rate from baseline
Time frame: Study Day 4
heart rate measured in beats per minute; baseline = Day -1
Change in respiratory rate from baseline
Time frame: Study Day 4
respiratory rate measured in breaths per minute; baseline = Day -1
Change in temperature from baseline
Time frame: Study Day 4
temperature measured in degrees Celsius; baseline = Day -1
Change in electrocardiogram (ECG) from baseline
Time frame: Study Day 3
overall physician interpretation of ECG reading; baseline = Day -1
Change in the Columbia Suicide Severity Rating Scale (C-SSRS) from baseline
Time frame: Study Day 8
The C-SSRS assesses suicidal ideation and behavior; baseline = Day -1
5 secondary outcomes
Change from baseline in quantitative electroencephalogram (qEEG)
Time frame: Study Day 4
Change from baseline in evoked response potential (ERP) amplitude
Time frame: Study Day 4
Change from baseline in evoked response potential (ERP) latency
Time frame: Study Day 4
Change from baseline in amplitude of mismatch negativity (MMN) ERP
Time frame: Study Day 4
Change from baseline in latency of mismatch negativity (MMN) ERP
Time frame: Study Day 4
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 27 Apr 2022.
- Individual participant dataSharing planned: No
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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.
David Walling, PhD principal investigator
Collaborative Neuroscience Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RL-007 in people with Cognitive Impairment and Schizophrenia, run by Recognify Life Sciences at 1 site in United States.
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 13 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 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Incidence of Treatment-emergent Adverse Events (TEAE) (time frame: Study Day 8.). The study lists 7 primary outcomes in all. 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 27 Apr 2022.