ProCAN
Psychosis Risk Outcomes Network, a project of the Accelerating Medicines Partnership for Schizophrenia
A NATIONWIDE CLINICAL TRIAL to better understand EARLY PSYCHOSIS RISK AND DEVELOP NEW TREATMENT STRATEGIES
(UCLA IRB #21-XXXXXX)
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ProCAN
The Psychosis Risk Outcomes Network, or ProCAN, focuses on young people who may be experiencing clinical high-risk (CHR) symptoms for psychosis. CHR symptoms are milder forms of psychosis-like experiences. For many people, these symptoms may stay the same, decrease, or go away entirely over the course of a few months or years. For others, symptoms may become more severe over time and develop into psychosis.
The onset of psychosis disproportionately impacts young people. Each year, an estimated 100,000 young people in the United States experience a first episode of psychosis. Early identification and treatment can improve outcomes, including reduced symptom severity, improved long-term quality of life, and lower personal, family, and economic burden.
UCLA CAPPS is participating in the first ProCAN study, a national proof-of-principle clinical trial evaluating MT1988, an investigational medication from Monument Therapeutics. The study compares two dose levels of MT1988 with placebo over an 8-week treatment period in young people at clinical high risk for psychosis.
This study is designed to explore how MT1988 affects clinical, cognitive, biological, genetic, and digital markers over time. ProCAN includes clinical interviews, cognitive and neuropsychological testing, EEG, EKGs, blood and saliva samples, safety monitoring, and digital assessments.
ProCAN is part of the Accelerating Medicines Partnership in Schizophrenia, or AMP SCZ, a public-private research effort that brings together the NIH, the Foundation for the NIH, private foundations, and industry partners to accelerate the development of new treatments through large-scale research initiatives.
Through this work, ProCAN aims to help researchers better understand early psychosis risk, identify meaningful markers of change, and support the development of future treatment strategies for young people with mental health concerns.
Eligibility
The ProCAN study is recruiting young people who may be at clinical high risk, or CHR, for psychosis. Some individuals may be at higher risk of developing psychosis than others, and this study is focused on people who are experiencing early changes in thinking, behavior, communication, or perception.
To be eligible, you must:
- Be between the ages of 17 and 30 years old
- Live in or near the Los Angeles area
- Be able to understand and sign an informed consent document, or an assent document for minors when applicable
- Be willing and able to complete scheduled study visits and procedures
You may be eligible if you have experienced changes in thinking, behavior, or experiences, such as:
- Confusion about what is real or imaginary
- Feeling not in control of your own thoughts or ideas
- Feeling suspicious or paranoid
- Having experiences that may not be real, such as hearing sounds or seeing things that may not be there
- Having trouble communicating clearly
- Subtle perceptual changes, unusual thoughts, or noticeable changes in functioning
You may not be eligible if you have a prior history of psychosis, a significant neurological or medical condition affecting the central nervous system, a recent traumatic brain injury, or current medical, psychiatric, medication, or safety concerns that would make study participation unsafe or difficult to complete.
FAQ
If I do participate in the study, what is required of me?
Participation in ProCAN lasts approximately 15 weeks. This includes a screening period, an 8-week treatment period, and a follow-up period.
If you are eligible and choose to enroll, you will be asked to come to the clinic for study visits over the course of the study. These visits may include clinical interviews, cognitive testing, biological assessments, safety monitoring, and study medication or placebo.
If you are eligible to participate, study procedures include:
- Clinical interviews: These focus on your daily life, mood, functioning, symptoms, and experiences.
- Cognitive and neuropsychological testing: These assessments focus on memory, attention, concentration, learning, and related thinking skills.
- Biological assessments: These include blood samples, saliva samples, and EEG.
- Safety assessments: These include EKGs, vital signs, safety labs, urine testing, and monitoring for side effects.
- Digital assessments: These involve use of the mindLAMP app to collect information related to daily functioning, movement, rest-activity patterns, and phone sensor data.
- Study medication or placebo: Eligible participants are randomly assigned to receive lower-dose MT1988, higher-dose MT1988, or placebo.
What is MT1988?
MT1988 is an investigational medication from Monument Therapeutics. It is being studied as part of ProCAN to better understand how it affects clinical, cognitive, biological, and digital markers in young people at clinical high risk for psychosis.
MT1988 uses a novel, non-D2-blocking mechanism. It is a fixed-dose combination of two medications designed to enhance nicotinic signaling, a pathway linked to attention, memory, and cognitive processing.
What are the benefits of participating in this research study?
In addition to contributing to the advancement of knowledge about early psychosis, you will learn more about your own mental health. You may receive recommendations for treatment and additional support through symptom monitoring, psycho-education sessions, and investigational medication or placebo. We can also share this information with your provider to collaborate in evaluating your treatment options. You will also receive financial compensation for your participation in the study.
What are clinical high-risk symptoms, and how do they differ from first-episode psychosis?
Clinical high risk (CHR) for psychosis syndrome includes symptoms that are similar to, but less severe than, the symptoms of first episode psychosis. Symptoms of clinical high risk (CHR) for psychosis include the emergence of unusual and unrealistic thoughts, feelings of suspiciousness toward others, feelings of special powers or abilities, uncertainty about hearing or seeing things that others do not notice, and having trouble organizing thoughts. These (CHR) symptoms signal elevated risk for psychosis. In first episode psychosis, individuals experience their symptoms as definitively real.
Why is this study important?
ProCAN is a nationwide clinical trial funded by the Accelerating Medicines Partnership in Schizophrenia (AMP-SCZ) program—a major public-private partnership between the NIH, the FNIH, the U.S. Food and Drug Administration (FDA), and several pharmaceutical and life science companies, in addition to non-profit foundations and other organizations. Together, they aim to tackle urgent biomedical problems, with current initiatives including Alzheimer’s disease, Parkinson’s disease, Type 2 Diabetes, and most recently, Early Intervention in Schizophrenia.
Early identification and intervention may improve outcomes for people at clinical high risk for psychosis. ProCAN is part of a larger effort to better understand early risk states and identify meaningful markers that may guide future treatment development.
This study focuses on how cognitive, clinical, biological, genetic, and digital biomarkers change over time in the presence of MT1988. Establishing reliable biomarkers may help researchers better understand how treatments work, optimize early intervention strategies, and inform the development of future treatments for young people at risk for psychosis.
The insights that result from the ProCAN study will serve as the foundation for the development of treatments through AMP SCZ that can transform long-term outcomes for those at clinical high risk for developing first episode psychosis—the broader goal is to develop tools that help define early stages of risk, predict clinical outcomes, and support future treatment development.