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)
- Conditions
- Schizophrenia, Cognitive disorderMedDRA version: 20.0Level: PTClassification code: 10039626Term: Schizophrenia Class: 100000004873MedDRA version: 21.1Level: PTClassification code: 10057668Term: Cognitive disorder Class: 100000004852Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2023-506570-12-01
- Lead Sponsor
- Recognify Life Sciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 234
Is an adult of any sex, gender, and race/ethnicity between 18 and 55 years of age, inclusive, at time of consent., Have a body mass index (BMI) =40.0 kg/m2 at the time of screening., Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the Schedule of Assessments., If the participant is a current smoker, they must be willing to abstain from smoking or other nicotine products for the 30 minutes prior to the cognitive testing., Participant has reliable housing that is not expected to change during the study period with no expected significant life events (e.g., pending loss of housing, residential status change, travel, surgery, etc.) that could affect study outcomes throughout entire study period., Sufficient fluency in the local country language to understand and complete study instructions and assessments., Willing and able* to provide written informed consent. *Defined as having the legal capacity to independently sign the informed consent. Participants with a legal guardian are not eligible to enroll., If participant is of child-bearing potential*, has a negative serum pregnancy test at screening and negative urine pregnancy test before dosing., Is unable* to become pregnant or father a child, or agrees to be sexually abstinent or use a highly effective method of contraception from screening through 90 days post last dose and not to donate sperm or ovum(s) during this period. *See Appendix 1 for definition and guidance on acceptable contraception methods., Diagnosis of schizophrenia, as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) with a duration of least 6 months. The diagnosis will be confirmed by utilizing the Mini International Neuropsychiatric Interview (MINI) with the Psychotic Disorders module., Positive and Negative Symptoms Severity Score (PANSS) of less than or equal to 80 (inclusive), and a score of 5 or less on the following items: hallucinatory behavior (P3), grandiosity (P5), suspiciousness/persecution (P6), depression (G6) and a score of 4 or less on conceptual disorganization (P2)., Currently being treated with a single atypical antipsychotic* (other than clozapine) at a stable dose (defined as ±25% at least 1 month ago and no changes since) and must have been on that medication and clinically stable (defined as not requiring a change in treatment or any psychiatric care beyond regularly scheduled appointments) for at least 4 weeks before the screening visit. *Note: long-acting injectables are allowed. Participants need to be stable on a maintenance dose for at least one completed injection cycle before as per local prescribing information before screening start. Quetiapine (up to 100 mg, per night PRN), when used in addition to another antipsychotic medication is allowed when taken at least 12 hours prior to cognitive testing., Modified Simpson-Angus Scale total score < 6, with all individual item scores < 3., Clinical Global Impression – Severity score <5., Is judged otherwise to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of study drug.
Known sensitivity to any of the planned study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or Sponsor, contraindicates participation in the study., Has an active malignancy, or history of malignancy, excluding basal or squamous cell carcinoma of the skin, within 2 years prior to screening., History of cardiovascular, cerebrovascular, or peripheral vascular disease 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. Clinically significant screening values measured after 5 minutes of rest in a seated position include: a)Abnormal systolic blood pressure (<90 or >145 mmHg) b)Abnormal diastolic blood pressure (<40 or >95 mmHg) c)Abnormal respiratory rate (<10 or >22 breaths per minute), Has a clinically significant history or presence of electrocardiogram (ECG) findings as judged by the Principal Investigator (PI) or designee at screening, including: a)HR <40 bpm or > 100 bpm b)Average QT interval corrected using Fridericia’s formula (QTcF) interval duration >450 ms for males and >470 ms for females c)Average QRS interval >120 ms d)Average PR interval >220 ms, Has clinically significant laboratory abnormalities including alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST) laboratory values >2 × upper limits of normal (ULN) and 1.5 × ULN for bilirubin unless isolated Gilbert’s syndrome. Note: Laboratory screening can be repeated once, at Investigator discretion., 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). *Note: see Section 7.19 and Appendix 4 for further guidance on allowed/prohibited concomitant medications., Positive serology panel (including hepatitis B surface antigen [HBsAg] and/or confirmed current hepatitis C virus [HCV] infection [positive HCV antibody confirmed with reflex HCV RNA test]) and/or positive human immunodeficiency virus (HIV) antibody/p24 antigen screen., Has received treatment with another investigational drug, investigational device, or approved therapy for investigational use within 30 days or 5 half-lives (whichever is longer) prior to dosing; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable., Participant has undergone electroconvulsive therapy within the past 12 months., Has donated blood or plasma within 30 days prior to randomization or had a loss of whole blood of more than 500 mL within the 30 days prior to randomization, or receipt of a blood transfusion within 1 year prior to randomization., Has experienced symptoms of acute illness or chronic disease within 14 days prior to screening, or any disease or condition (medical or surgical) that, by the determination of the Investigator or Sponsor, might compromise interpretation of the study data, or would place the participant at risk as a result of taking part in the study., Prior exposure to RL-007, Participants with needle phobia or in whom venous access is technically difficult., Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the participant unsuitable for enrol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method