MT1988 for High Risk of Psychosis

Not yet recruiting at 14 trial locations

Overseen By Sheryl Caswell

Age: < 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Monument Therapeutics Limited

Must not be taking: Antipsychotics, others

Disqualifiers: Schizophrenia, Cognitive disorder, Suicide risk, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, MT1988, to determine its effect on tests used to identify changes in individuals at high risk of developing psychosis. Researchers aim to observe whether these tests change when participants take different doses of MT1988 compared to a placebo (a pill with no active medicine). Participants will take the medication twice daily for 8 weeks and attend check-ups every two weeks. Individuals diagnosed with a high risk of psychosis who can comply with trial requirements may be suitable for this study. As a Phase 1, Phase 2 trial, this study focuses on understanding how MT1988 works in people and measuring its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not clearly state if you must stop taking your current medications, but it mentions that current use of medications that could interfere with the study will be assessed by the investigator. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MT1988 has been safe in earlier studies. In a previous study, participants tolerated MT1988 well, with no major safety issues, prompting further testing.

While more information is needed, positive results from earlier trials suggest that MT1988 might be safe to use. These trials typically indicate that any side effects are manageable and not serious. Participants reported side effects during these trials, which helped researchers learn more about the treatment.

In summary, earlier research suggests MT1988 is safe, but it remains important to monitor participants closely for any side effects during the trial. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for psychosis?

Researchers are excited about MT1988 because it offers a new approach to managing high risk of psychosis. Unlike traditional antipsychotics, which primarily target dopamine receptors, MT1988 works through a novel mechanism that researchers believe could provide benefits with potentially fewer side effects. The trial is testing both low and high doses of MT1988, which could help determine the most effective way to use this treatment for those at risk. This innovative approach might open new doors for early intervention and prevention in psychosis, offering hope for improved outcomes compared to current treatments.

What evidence suggests that MT1988 might be an effective treatment for high risk of psychosis?

Studies have shown that MT1988 is designed to work with current medications for schizophrenia to improve thinking skills, such as memory and attention. Early results suggest MT1988 might address these cognitive issues, which existing drugs often struggle to treat. Research indicates that people at high risk of developing psychosis might benefit from MT1988 by potentially enhancing their cognitive abilities. This trial will evaluate different dosages of MT1988, including low and high doses, to determine its effectiveness. This could represent a major breakthrough for those showing early signs of schizophrenia. However, more studies are needed to confirm these effects specifically in people at high risk of psychosis. ^{1 2 6 7 8}

Who Is on the Research Team?

Scott Woods, M.D.

Principal Investigator

Yale University of Medicine

Martha E Shenton, PhD

Principal Investigator

Massachusetts General Brigham

Are You a Good Fit for This Trial?

This trial is for young adults aged 17 to 30 who are at high risk of developing psychosis but have not yet been diagnosed with schizophrenia. Participants will be taking a new medication or placebo and must be able to attend bi-weekly clinic appointments.

Inclusion Criteria

I am between 17 and 30 years old.

For females of reproductive potential - not pregnant or nursing and willing to comply with contraceptive requirements

I am at high risk for developing psychosis.

Exclusion Criteria

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

Clinically significant medical disorder or laboratory test abnormality at Day 1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MT1988 or placebo twice daily for 8 weeks

8 weeks

Clinic appointments every two weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MT1988

Trial Overview The study tests the effects of two different doses of MT1988 compared to a placebo over an 8-week period, focusing on changes in biomarkers that could indicate the drug's effectiveness in individuals at high risk for psychosis.

How Is the Trial Designed?

Group I: MT1988 Low Dose Experimental Treatment 1 Intervention

Group II: MT1988 High Dose Experimental Treatment 1 Intervention

Group III: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Monument Therapeutics Limited

Lead Sponsor

Trials

2

Recruited

70+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Foundation for the National Institutes of Health

Collaborator

Trials

16

Recruited

5,800+

ProCAN

Collaborator

CT-DPACC

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07226895

A Study Exploring Changes in a Variety of Biomarkers ... Past or current schizophrenia, other disorder with symptoms of psychosis, major cognitive disorder resulting from traumatic brain injury.

2. wjhl.com wjhl.com/business/press-releases/ein-presswire/823442753/monument-therapeutics-reports-positive-phase-i-results-for-novel-cognitive-impairment-in-schizophrenia-treatment

Monument Therapeutics Reports Positive Phase I Results ... MT1988 is designed to be used alongside existing anti-psychotic medications for schizophrenia, to address the cognitive symptoms that have long ...

3. ctv.veeva.com ctv.veeva.com/study/a-study-exploring-changes-in-a-variety-of-biomarkers-following-dosing-with-mt1988-in-participants-at

A Study Exploring Changes in a Variety of Biomarkers ... Past or current schizophrenia, other disorder with symptoms of psychosis, major cognitive disorder resulting from traumatic brain injury.

4. cambridgecognition.com cambridgecognition.com/cambridge-cognition-investment-monument-therapeutics-announces-partnership-with-foundation-for-the-national-institutes-of-health-for-clinical-trial-of-mt1988-a-novel-treatment-for-schizophrenia/

19 August 2025 The initiative aims to accelerate the development of more effective treatments for schizophrenia and related mental health conditions. Cambridge ...

5. monumenttx.com monumenttx.com/news/monument-therapeutics-announces-partnership-with-foundation-for-the-national-institutes-of-health-for-clinical-trial-of-mt1988-a-novel-treatment-for-schizophrenia/

Monument Therapeutics Announces Partnership with ... Many individuals begin to show signs of schizophrenia months or even years before receiving a diagnosis. This period, referred to as the ' ...

6. pharmexec.com pharmexec.com/view/monument-therapeutics-announces-collaboration-foundation-national-institutes-of-health-on-clinical-trial-for-schizophrenia-treatment

Monument Therapeutics Announces Collaboration with the ... The trial will involve 150 clinically high-risk patients, assessing MT1988's efficacy using clinical and cognitive biomarkers. The study is ...

7. bddpharma.com bddpharma.com/bdds-phase-1-trial-reports-positive-phase-i-results-for-novel-cognitive-impairment-associated-with-schizophrenia-treatment/

BDD's Phase 1 Trial Reports Positive Phase I Results for ... The successful outcome, demonstrating a favourable safety profile and good tolerability, supports advancing MT1988 into Phase II clinical trials ...

8. monumenttx.com monumenttx.com/news/monument-therapeutics-launches-first-clinical-study-of-mt1988-a-novel-treatment-for-cognitive-impairment-associated-with-schizophrenia/

Monument Therapeutics Launches First Clinical Study of ... This Phase I placebo-controlled trial is designed to evaluate the safety, tolerability and pharmacokinetics of MT1988 in healthy adults over a ...