Recruiting

Phase 1

Phase 2

MT1988A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis

Sponsor:

Monument Therapeutics Limited

Code:

NCT07226895

Conditions

Clinical High Risk for Psychosis (CHR)

Eligibility Criteria

Sex: All

Age: 17 - 30

Healthy Volunteers: Not accepted

Interventions

MT1988 Low Dose

MT1988 High Dose

Placebo

Study Details

Brief summary:

The goal of this clinical trial is to learn how tests undertaken by people at high risk of developing psychosis (aged 17 to 30 years old) change when those people are given the study drug MT1988 daily for 8 weeks. This will help identify tests that could be used in later trials developing treatments for symptoms in people at high risk of developing psychosis, to measure whether those new treatments are effective.

The main question this trial aims to answer is:

Can any of the tests (biomarkers) used in this study detect changes in participants dosed with one of two different dose levels of MT1988?

Researchers will compare the results from two dose levels of MT1988 to a placebo group. Researchers do not expect to see the test results change in participants taking placebo and this will be compared to changes expected in test results in participants taking MT1988.

Participants will:

take a dose of MT1988 or placebo twice per day for 8 weeks
attend clinic appointments every two weeks to undertake assessments
report any side effects they experience to the researchers

Conditions

Clinical High Risk for Psychosis (CHR)

Study ID

NCT07226895

Start date

Mar 3, 2026

Status verified date

Jun, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 17 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

Aged 17 to 30 years at time of consent.
Capacity to provide informed consent. (For patients under 17 years, participants must assent and informed consent provided by one parent or legal guardian).
Meet diagnostic criteria for Clinical High Risk of Psychosis (CHR).
For females of reproductive potential - not pregnant or nursing and willing to comply with contraceptive requirements.

Exclusion Criteria:

Clinically significant medical disorder or laboratory test abnormality at Day 1.
History of or current condition which may prevent participant from complying with study procedures.
Past or current schizophrenia, other disorder with symptoms of psychosis, major cognitive disorder resulting from traumatic brain injury.
Received antipsychotic medication equivalent to a total lifetime haloperidol dose >50 mg.
Current use of medications which could interfere with the study endpoints - to be assessed by the Investigator at screening.
Unable to abstain from nicotine (e.g. cigarettes, vape) for two hours before cognitive testing.
Unable to abstain from marijuana use on test day prior to test completion.
History of suicide attempt or behavior in previous 12 months, or risk of suicidal behavior during the study.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: MT1988 Low Dose

experimental: MT1988 High Dose

placebo comparator: Placebo

Interventions

MT1988 Low Dose

Oral dosing MT1988; dose level 1

MT1988 High Dose

Oral dosing MT1988; dose level 2

Placebo

Oral Placebo; blinded to match MT1988 all doses

Primary outcome measure

Change from baseline to week 8 in test of verbal memory (List Learning Task) as measured by the Penn Computerized Neurobehavioral Battery (PennCNB) test battery [ Time Frame: Day 56 ]
Change from baseline to week 8 in attenuated positive symptoms as measured by PSYCHS-CT total score [ Time Frame: Day 56 ]
Change from baseline to week 8 in negative symptoms as measured by the Negative Symptom Inventory - Psychosis Risk (NSI-PR) total score [ Time Frame: Day 56 ]

Central Contacts and Locations

Central contacts

Sheryl Caswell

+447539430768 info@monumenttx.com

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Jason Schiffman

443-722-7768 jason.schiffman@uci.edu

University of California

Recruiting

Los Angeles, California, United States, 90095

Contacts

Carrie Bearden

310-206-3466 cbearden@mednet.ucla.edu

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94107

Contacts

Daniel Mathalon

415-221-4810 daniel.mathalon@ucsf.edu

Yale University Conneticut Mental Health Center

Recruiting

New Haven, Connecticut, United States, 06519

Contacts

Scott Woods

203-200-8997 scott.woods@yale.edu

Munaza Ali

203-200-8997 munaza.ali@yale.edu

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

William Stone

508-740-2050 wstone@bidmc.harvard.edu

Washington University

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Daniel Mamah

314-273-4329 mamahd@wustl.edu

Malana Kanallakan

314-273-4329 malana@wustl.edu

Northwell Health

Recruiting

Glen Oaks, New York, United States, 11004

Contacts

Ricardo Carrion

347-502-1909 RCarrion@northwell.edu

Columbia University

Recruiting

New York, New York, United States, 10032

Contacts

Ragy Girgis

646-774-5553 ragy.girgis@nyspi.columbia.edu

Joshua Kantrowitz

646-774-6738 Joshua.kantrowitz@nyspi.columbia.edu

Icahan School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10128

Contacts

Cheryl Corcoran

212-659-1671 cheryl.corcoran@mssm.edu

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Diana Perkins

877-774-6319 PRIME@med.unc.edu

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Nicholas Breitborde

614-398-2991 nicholas.breitborde@osumc.edu

Prevention Science Institute

Recruiting

Eugene, Oregon, United States, 97403

Contacts

Fred Sabb

310-844-6458 fws@uoregon.edu

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Daniel Wolf

215-662-3692 danwolf@pennmedicine.upenn.edu

Christian Kohler

kohler@pennmedicine.upenn.edu

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19122

Contacts

Lauren Ellman

215-204-1571 ellman@temple.edu

University of Pittsburgh School of Medicine

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Leslie Horton

412-864-7006 hortonle2@upmc.edu

More Information

Sponsor

Monument Therapeutics Limited

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Monument Therapeutics Limited on 2026-06-08.