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Study on RL-007 for Improving Cognitive Impairment in Schizophrenia Patients

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called RL-007 on individuals with schizophrenia, specifically targeting cognitive impairment associated with this condition. Schizophrenia is a mental health disorder that affects a person's ability to think, feel, and behave clearly. Cognitive impairment refers to difficulties with memory, attention, and problem-solving skills, which are common in people with schizophrenia. The study will compare the effects of RL-007, which is taken in capsule form, to a placebo, which looks like the treatment but does not contain the active substance.

The purpose of the study is to evaluate the safety and effectiveness of RL-007 in improving cognitive performance in participants diagnosed with schizophrenia. Participants will be randomly assigned to receive either RL-007 or a placebo, and neither the participants nor the researchers will know who is receiving which treatment. This is known as a double-blind study. The study will last for a period of six weeks, during which participants will take the medication orally and attend regular study visits for assessments.

Throughout the study, participants will undergo various tests to measure changes in their cognitive abilities, such as memory and attention, as well as overall health checks, including vital signs and laboratory tests. The study aims to provide valuable information on whether RL-007 can help improve cognitive function in people with schizophrenia, potentially leading to better treatment options in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and Baseline Assessment
Upon joining the study, participants undergo a baseline assessment. This includes a review of medical history, a physical examination, and laboratory tests to ensure good health.
Participants are required to have a stable treatment with a single atypical antipsychotic medication, excluding clozapine, for at least four weeks prior to the screening.
Step 2
Randomization
Participants are randomly assigned to receive either the study medication RL-007 or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.
The medication is administered in the form of capsules taken orally.
Step 3
Medication Administration
Participants take the assigned capsules daily for a period of six weeks. The exact dosage and frequency are determined by the study protocol.
Step 4
Mid-Study Assessments
At Week 3, participants undergo a series of assessments, including vital signs measurement, physical examination, and a review of any side effects.
These assessments help monitor the participant's health and the medication's effects.
Step 5
Final Study Assessments
At Week 6, participants complete the final assessments, which include cognitive tests to measure changes in cognitive performance.
Additional evaluations include vital signs, physical examination, ECG, and laboratory tests.
Step 6
Follow-Up
Participants are monitored for any side effects or changes in health for two weeks after the final dose of the study medication.
This follow-up period ensures the safety and well-being of the participants after the study concludes.

Who can join the trial?

15 criteria

Must be an adult between 18 and 55 years old.
Have a body mass index (BMI) of 40.0 or less. BMI is a measure of body fat based on height and weight.
Agree to attend all study visits and follow the study rules.
If a smoker, must not smoke or use nicotine products for 30 minutes before cognitive tests.
Have stable housing and no major life changes expected during the study.
Must understand and speak the local language well enough to follow study instructions.
Willing and able to sign a consent form to participate in the study.
If able to have children, must have a negative pregnancy test before starting the study.
If able to have children, must agree to use effective birth control or not engage in sexual activity during the study and for 90 days after the last dose.
Have a diagnosis of schizophrenia for at least 6 months, confirmed by a specific interview.
Have a Positive and Negative Symptoms Severity Score (PANSS) of 80 or less, with specific item scores meeting certain criteria. PANSS is a tool used to measure symptoms of schizophrenia.
Currently taking a single atypical antipsychotic medication, except clozapine, at a stable dose for at least 4 weeks before the study. Atypical antipsychotics are a type of medication used to treat schizophrenia.
Have a Modified Simpson-Angus Scale total score of less than 6. This scale measures side effects of antipsychotic medications.
Have a Clinical Global Impression – Severity score of less than 5. This score assesses the severity of the condition.
Be in good health based on medical history, physical exam, and lab tests.

Who cannot join the trial?

4 criteria

Participants who do not have a diagnosis of schizophrenia cannot join the study. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves.
Participants who do not have a cognitive disorder cannot join the study. A cognitive disorder affects a person's ability to think, remember, or learn.
Participants who are not within the specified age range for the study cannot join. The age range is determined by the study organizers.
Participants who belong to a vulnerable population, which means they might need special protection or care, cannot join the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Center for Mental Health “Prof. N. Shipkovenski” EOOD
Sofia, Bulgaria
Verified
Centrum Medyczne Luxmed Sp. z o.o.
Lublin, Poland
Responsive
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv, Bulgaria

Trial locations

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Investigated drugs

RL-007 is a medication being studied for its potential to improve cognitive performance in people diagnosed with schizophrenia. The trial aims to evaluate the safety and effectiveness of this medication in treating cognitive impairment associated with schizophrenia.

(2R,3S)-2-Amino-3-Hydroxy-3-Pyridin-4-Yl-1-Pyrrolidin-1-Ylpropan-1-One (2R,3R)-2,3-Dihydroxybutanedioic Acid

What is already known about the treatment

RL-007 – RL-007 is administered orally in the form of tablets. It is currently being studied in clinical trials to evaluate its safety and effectiveness in treating cognitive impairment associated with schizophrenia. The main therapeutic indication for RL-007 is to improve cognitive performance in individuals diagnosed with schizophrenia. At the molecular level, RL-007 is believed to enhance neurotransmitter activity, which may help improve cognitive functions. It is classified pharmacologically as a cognitive enhancer.

Investigated diseases

Schizophrenia
Schizophrenia is a chronic mental health disorder that affects how a person thinks, feels, and behaves. It often involves symptoms such as hallucinations, delusions, and disorganized thinking. Individuals with schizophrenia may experience a reduced ability to function in daily life. The disorder typically emerges in late adolescence or early adulthood. It can lead to difficulties in maintaining relationships and employment. The progression of symptoms can vary, with periods of worsening and improvement.
Cognitive Disorder
Cognitive disorder refers to a condition that affects cognitive functions such as memory, attention, and problem-solving. These disorders can result from various causes, including brain injury, neurological diseases, or mental health conditions. Individuals may experience difficulties in processing information, learning new things, or making decisions. The severity and progression of cognitive disorders can vary widely. Some people may experience gradual decline, while others may have more sudden changes. The impact on daily life can range from mild to severe, depending on the extent of cognitive impairment.