Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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)

This research study is testing a new medication called RL-007 for people living with schizophrenia. Schizophrenia can sometimes affect how people think, learn, and remember, which doctors call 'cognitive impairment.' The study aims to find out if RL-007 can safely help improve these thinking skills. It's a 'Phase II' study, which means it's an important early stage of testing to see if the medication works and how it affects people. Participants will receive either RL-007 or a dummy pill (placebo), and various tests will be used to measure any changes in their thinking, memory, and overall well-being over several weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Recognify Life Sciences Inc.

Enrolment target

164

Start

23 May 2024

Cognitive disorder Schizophrenia

What is this study about?

This research study is about finding better ways to help people who have schizophrenia. Sometimes, schizophrenia can make it harder for people to think clearly, remember things, pay attention, or solve problems. Doctors call these 'cognitive impairments' or 'cognitive impairment associated with schizophrenia' (CIAS).

Researchers are testing a new medication called RL-007 to see if it can improve these thinking and memory skills. This is an important step because if RL-007 proves to be safe and helpful, it could offer a new treatment option in the future to improve the daily lives of people with schizophrenia.

The study is designed very carefully. Some participants will receive RL-007, and others will receive a 'placebo,' which looks just like the real medicine but contains no active drug. This helps researchers understand if any improvements are truly due to the medication or something else. Neither the participants nor their doctors will know who is getting which, to keep the results as fair and accurate as possible.

Key takeaways

This study is testing a new medication (RL-007) for thinking and memory difficulties in people with schizophrenia.
It's a Phase II study, focusing on safety and effectiveness.
Participants will receive either RL-007 or a dummy pill (placebo).
Thinking skills, memory, and general health will be regularly checked.
The study lasts about eight weeks for each participant.
Joining is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

While the main requirements are being an adult with schizophrenia and experiencing some difficulties with thinking and memory, there will be other health checks to make sure the study is safe for you. For example, your overall health will be checked to make sure it's okay for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with schizophrenia?
Are you experiencing difficulties with your thinking, memory, or attention?
Are you generally in good enough health to participate in a study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to either receive the new medication RL-007 or a dummy pill (placebo). Neither you nor your doctor would know which one you are getting.

You would have several visits over about eight weeks. During these visits, there would be tests to check your thinking, memory, and attention skills. These tests help understand if the medication is making a difference. You would also have regular health check-ups, including blood tests, physical exams, heart checks (ECGs), and monitoring of your blood pressure and heart rate to ensure your safety.

The study would involve taking the medication (or placebo) for six weeks, with follow-up assessments until week eight. Your overall well-being and any side effects would be carefully monitored throughout.

Potential risks and benefits

Taking part in a study like this could offer the benefit of potentially improving your thinking, memory, and attention skills if RL-007 proves to be effective. You would also be contributing to medical science, which could help many others in the future. However, there are potential risks, just like with any medication, such as experiencing side effects which will be carefully monitored. You also might not receive the active medication. It's very important to remember that joining is completely voluntary, and you are free to stop participating at any time without explaining your reasons, and this will not affect your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland
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Unverified
Bulgaria
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Unverified
Czechia

Common questions

What is schizophrenia?

Schizophrenia is a long-term mental health condition that can cause a range of psychological symptoms, including changes in thoughts, feelings, and behaviours.

What does 'cognitive impairment' mean?

It means having difficulties with thinking, remembering, learning, paying attention, or solving problems.

What is a 'placebo'?

A placebo is a dummy pill that looks like the real medication but doesn't contain any active drug. It helps researchers compare the effects of the new medication fairly.

Will I know if I'm getting the real medicine?

No, neither you nor your doctor will know if you are getting RL-007 or the placebo during the study. This helps keep the study fair and accurate.

How long will the study last for me?

If you join, your active participation would involve taking medication for six weeks, with a total of about eight weeks for all assessments and follow-up.