In our last post, we explored how the clinical high risk (CHR) for psychosis stage can reveal the earliest cognitive and neurobiological impairments linked to psychosis risk, offering an important opportunity to evaluate treatments aligned with those mechanisms. This week, we introduce the scientific and clinical leaders who are driving that work forward through our MT1988 proof-of-principle clinical trial.
A Mission Built on Collaboration
Developing treatments and improving outcomes for individuals at risk for schizophrenia requires expertise that spans clinical psychiatry, neurobiology, cognitive neuroscience, biomarker development, and patient-centered study operations. That’s why our approach is rooted in collaboration.
Through Monument’s partnership with the Foundation for the National Institutes of Health (FNIH) and the broader scientific community through the Accelerating Medicines Partnership® Schizophrenia (AMP® SCZ) programme, Monument is working alongside world-leading experts to accelerate progress in early psychosis care. AMP SCZ brings together academic, nonprofit, industry, and government partners to ensure that emerging treatments are guided by robust science and delivered where they can have the greatest impact.
The MT1988 AMP SCZ PoP clinical trial will be led by an exceptional team of internationally recognized experts in psychosis-risk research, including:
- Dr Scott Woods & Dr Youngsun Cho, Yale School of Medicine
- Dr Martha Shenton & Dr Ofer Pasternak, Brigham and Women’s Hospital
- Dr Carrie Bearden, University of California, Los Angeles
- Dr John Kane, Northwell Health
- Dr Sylvain Bouix, École de technologie supérieure, Université du Québec
- Dr René Kahn, Icahn School of Medicine at Mount Sinai
Monument’s role in this partnership reflects our focus on precision psychiatry: developing mechanistically informed treatments alongside biomarkers that can identify who is most likely to benefit. The AMP SCZ clinical trial reflects years of work, built on a strong scientific foundation aimed at addressing early disruptions that influence the trajectory towards psychosis.
Meet the Investigators Shaping the Future
Each investigator brings deep expertise in early psychosis and a shared belief in the promise of CHR-focused treatment. We asked a couple of the Principal Investigators about their motivation and perspective as the study prepares to get underway.
Q: What makes the CHR population uniquely important to study?
Dr. Scott Woods: “CHR is a common condition, with a prevalence estimated in the general youth population of 1.7% and 19.2% at their first presentation for psychiatric treatment. Moreover, at least 78% of individuals who develop schizophrenia or other psychotic disorders experience a prodromal period similar to CHR, and longitudinal studies of CHR individuals estimate a 20% conversion to psychosis at 2 year follow-up. There are currently no medications approved by regulatory agencies for this clinical group, despite the clear clinical need and opportunity for preventative treatment.”
Q: Why are biomarkers a cornerstone of this trial?
Dr. Scott Woods: “AMP SCZ was established in 2020 to facilitate treatment development by generating tools informed by mechanistic process that identify level of risk for psychosis conversion and other potential treatment targets. The goal is for these tools to be used to stratify CHR individuals in clinical trials with novel therapeutics and to develop personalized treatments. These tools will bring us closer to other areas of medicine that use medical devices and other tools to facilitate treatment efficacy and to assess outcomes.
Q: How does this trial build on the fields collective knowledge?
Dr. Martha Shenton: “AMP SCZ is unifying how we measure and understand the CHR for psychosis population and the underlying disease pathways. One way that the MT1988 AMP SCZ PoP clinical trial builds on collective knowledge is through the use of primary outcome measures from the ongoing AMP SCZ observational study, including CHR biomarkers related to cognition, and the use of the “Positive SYmptoms and Diagnostic Criteria for the CAARMS Harmonized with the SIPS” (PSYCHS), which is a harmonized measure for identifying CHR status and tracking changes in psychotic-like CHR symptoms. This trial builds on that shared framework to test a therapeutic mechanism.”
Q: How can the outcomes of this trial advance early intervention more broadly?
Dr. Martha Shenton: “The hope is that the outcomes of this trial will advance early intervention and drug development by pointing towards pathophysiologically relevant mechanisms underlying the cognitive, clinical, neurophysiological, digitial, or biological outcome measures used in this clinical trial.”
Changing the Odds Together
Every step forward in CHR research is a step toward preserving life possibilities for the youth population who are at risk. The expertise and commitment of the team behind this trial create a powerful foundation for progress.
In our next post, we’ll dive deeper into the science behind MT1988 and the opportunity it presents to advance precision treatment.
Next release date: 17th November 2025.
Visit our website to read our blog series to date: www.monumenttx.com
To learn more about the FNIH, please visit fnih.org
To learn more about AMP SCZ, please visit fnih.org/AMP and www.ampscz.org
#FromSymptomstoSignals #PrecisionPsychiatry #Biomarkers #DrugDevelopment