[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610385":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":42,"locations":48,"responsibleParty":279,"collaborators":281,"id":290,"slug":291,"hasResults":292,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":11,"eligibilityCriteria":296,"healthyVolunteers":292,"sex":297,"minAge":298,"maxAge":299,"enrollmentInfo":300,"targetDuration":11,"studyType":303,"phases":304,"briefSummary":307,"conditions":308,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":319},{"fullName":5,"class":6},"Monument Therapeutics Limited","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"MT1988 Low Dose","EXPERIMENTAL",null,[13],"Drug: MT1988 Low Dose",{"label":15,"type":10,"description":11,"interventionNames":16},"MT1988 High Dose",[17],"Drug: MT1988 High Dose",{"label":19,"type":20,"description":11,"interventionNames":21},"Placebo","PLACEBO_COMPARATOR",[22],"Drug: Placebo",[24,28,31],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":11},"DRUG","Oral dosing MT1988; dose level 1",[9],{"type":25,"name":15,"description":29,"armGroupLabels":30,"otherNames":11},"Oral dosing MT1988; dose level 2",[15],{"type":25,"name":19,"description":32,"armGroupLabels":33,"otherNames":11},"Oral Placebo; blinded to match MT1988 all doses",[19],[35,39],{"name":36,"affiliation":37,"role":38},"Scott Woods, M.D.","Yale University of Medicine","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Martha E Shenton, PhD","Massachusetts General Brigham",[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Sheryl Caswell","CONTACT","+447539430768","info@monumenttx.com",[49,68,82,97,115,130,148,163,180,191,206,221,236,254,265],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"University of California, Irvine","RECRUITING","Irvine","California","92697","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-117.82311,33.66946,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":66,"phoneExt":11,"email":67},"Jason Schiffman","443-722-7768","jason.schiffman@uci.edu",{"facility":69,"status":51,"city":70,"state":53,"zip":71,"country":55,"countryCode":56,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"University of California","Los Angeles","90095",{"type":58,"coordinates":73},[74,75],-118.24368,34.05223,{"lat":75,"lon":74},[78],{"name":79,"role":45,"phone":80,"phoneExt":11,"email":81},"Carrie Bearden","310-206-3466","cbearden@mednet.ucla.edu",{"facility":83,"status":51,"city":84,"state":53,"zip":85,"country":55,"countryCode":56,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"University of California, San Francisco","San Francisco","94107",{"type":58,"coordinates":87},[88,89],-122.41942,37.77493,{"lat":89,"lon":88},[92],{"name":93,"role":45,"phone":94,"phoneExt":95,"email":96},"Daniel Mathalon","415-221-4810","23860","daniel.mathalon@ucsf.edu",{"facility":98,"status":51,"city":99,"state":100,"zip":101,"country":55,"countryCode":56,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Yale University Conneticut Mental Health Center","New Haven","Connecticut","06519",{"type":58,"coordinates":103},[104,105],-72.92816,41.30815,{"lat":105,"lon":104},[108,112],{"name":109,"role":45,"phone":110,"phoneExt":11,"email":111},"Scott Woods","203-200-8997","scott.woods@yale.edu",{"name":113,"role":45,"phone":110,"phoneExt":11,"email":114},"Munaza Ali","munaza.ali@yale.edu",{"facility":116,"status":51,"city":117,"state":118,"zip":119,"country":55,"countryCode":56,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02115",{"type":58,"coordinates":121},[122,123],-71.05977,42.35843,{"lat":123,"lon":122},[126],{"name":127,"role":45,"phone":128,"phoneExt":11,"email":129},"William Stone","508-740-2050","wstone@bidmc.harvard.edu",{"facility":131,"status":51,"city":132,"state":133,"zip":134,"country":55,"countryCode":56,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Washington University","St Louis","Missouri","63110",{"type":58,"coordinates":136},[137,138],-90.19789,38.62727,{"lat":138,"lon":137},[141,145],{"name":142,"role":45,"phone":143,"phoneExt":11,"email":144},"Daniel Mamah","314-273-4329","mamahd@wustl.edu",{"name":146,"role":45,"phone":143,"phoneExt":11,"email":147},"Malana Kanallakan","malana@wustl.edu",{"facility":149,"status":51,"city":150,"state":151,"zip":152,"country":55,"countryCode":56,"cosmosGeoPoint":153,"geoPoint":157,"contacts":158},"Northwell Health","Glen Oaks","New York","11004",{"type":58,"coordinates":154},[155,156],-73.71152,40.74705,{"lat":156,"lon":155},[159],{"name":160,"role":45,"phone":161,"phoneExt":11,"email":162},"Ricardo Carrion","347-502-1909","RCarrion@northwell.edu",{"facility":164,"status":51,"city":151,"state":151,"zip":165,"country":55,"countryCode":56,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Columbia University","10032",{"type":58,"coordinates":167},[168,169],-74.00597,40.71427,{"lat":169,"lon":168},[172,176],{"name":173,"role":45,"phone":174,"phoneExt":11,"email":175},"Ragy Girgis","646-774-5553","ragy.girgis@nyspi.columbia.edu",{"name":177,"role":45,"phone":178,"phoneExt":11,"email":179},"Joshua Kantrowitz","646-774-6738","Joshua.kantrowitz@nyspi.columbia.edu",{"facility":181,"status":51,"city":151,"state":151,"zip":182,"country":55,"countryCode":56,"cosmosGeoPoint":183,"geoPoint":185,"contacts":186},"Icahan School of Medicine at Mount Sinai","10128",{"type":58,"coordinates":184},[168,169],{"lat":169,"lon":168},[187],{"name":188,"role":45,"phone":189,"phoneExt":11,"email":190},"Cheryl Corcoran","212-659-1671","cheryl.corcoran@mssm.edu",{"facility":192,"status":51,"city":193,"state":194,"zip":195,"country":55,"countryCode":56,"cosmosGeoPoint":196,"geoPoint":200,"contacts":201},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27514",{"type":58,"coordinates":197},[198,199],-79.05584,35.9132,{"lat":199,"lon":198},[202],{"name":203,"role":45,"phone":204,"phoneExt":11,"email":205},"Diana Perkins","877-774-6319","PRIME@med.unc.edu",{"facility":207,"status":51,"city":208,"state":209,"zip":210,"country":55,"countryCode":56,"cosmosGeoPoint":211,"geoPoint":215,"contacts":216},"Ohio State University","Columbus","Ohio","43210",{"type":58,"coordinates":212},[213,214],-82.99879,39.96118,{"lat":214,"lon":213},[217],{"name":218,"role":45,"phone":219,"phoneExt":11,"email":220},"Nicholas Breitborde","614-398-2991","nicholas.breitborde@osumc.edu",{"facility":222,"status":51,"city":223,"state":224,"zip":225,"country":55,"countryCode":56,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Prevention Science Institute","Eugene","Oregon","97403",{"type":58,"coordinates":227},[228,229],-123.08675,44.05207,{"lat":229,"lon":228},[232],{"name":233,"role":45,"phone":234,"phoneExt":11,"email":235},"Fred Sabb","310-844-6458","fws@uoregon.edu",{"facility":237,"status":51,"city":238,"state":239,"zip":240,"country":55,"countryCode":56,"cosmosGeoPoint":241,"geoPoint":245,"contacts":246},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":58,"coordinates":242},[243,244],-75.16362,39.95238,{"lat":244,"lon":243},[247,251],{"name":248,"role":45,"phone":249,"phoneExt":11,"email":250},"Daniel Wolf","215-662-3692","danwolf@pennmedicine.upenn.edu",{"name":252,"role":45,"phone":11,"phoneExt":11,"email":253},"Christian Kohler","kohler@pennmedicine.upenn.edu",{"facility":255,"status":51,"city":238,"state":239,"zip":256,"country":55,"countryCode":56,"cosmosGeoPoint":257,"geoPoint":259,"contacts":260},"Temple University","19122",{"type":58,"coordinates":258},[243,244],{"lat":244,"lon":243},[261],{"name":262,"role":45,"phone":263,"phoneExt":11,"email":264},"Lauren Ellman","215-204-1571","ellman@temple.edu",{"facility":266,"status":51,"city":267,"state":239,"zip":268,"country":55,"countryCode":56,"cosmosGeoPoint":269,"geoPoint":273,"contacts":274},"University of Pittsburgh School of Medicine","Pittsburgh","15213",{"type":58,"coordinates":270},[271,272],-79.99589,40.44062,{"lat":272,"lon":271},[275],{"name":276,"role":45,"phone":277,"phoneExt":11,"email":278},"Leslie Horton","412-864-7006","hortonle2@upmc.edu",{"type":280,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[282,285,288],{"name":283,"class":284},"National Institute of Mental Health (NIMH)","NIH",{"name":286,"class":287},"Foundation for the National Institutes of Health","OTHER",{"name":289,"class":287},"Accelerating Medicines Partnership (AMP)","100610385","phase-1-a-study-exploring-changes-in-a-variety-of-biomarkers-following-dosing-with-mt1988-in-participants-at-clinical-high-risk-for-psychosis-100610385",false,"NCT07226895","A Study Exploring Changes in a Variety of Biomarkers Following Dosing With MT1988 in Participants at Clinical High Risk for Psychosis","A Study to Explore Changes in Cognitive, Clinical, Biological and Digital Measures Following 8 Weeks of Twice-daily Dosing of MT1988 and to Evaluate Safety & Tolerability of MT1988, in Participants at Clinical High Risk (CHR) for Psychosis","Inclusion Criteria:\n\n* Aged 17 to 30 years at time of consent.\n* Capacity to provide informed consent. (For patients under 17 years, participants must assent and informed consent provided by one parent or legal guardian).\n* Meet diagnostic criteria for Clinical High Risk of Psychosis (CHR).\n* For females of reproductive potential - not pregnant or nursing and willing to comply with contraceptive requirements.\n\nExclusion Criteria:\n\n* Clinically significant medical disorder or laboratory test abnormality at Day 1.\n* History of or current condition which may prevent participant from complying with study procedures.\n* Past or current schizophrenia, other disorder with symptoms of psychosis, major cognitive disorder resulting from traumatic brain injury.\n* Received antipsychotic medication equivalent to a total lifetime haloperidol dose \\>50 mg.\n* Current use of medications which could interfere with the study endpoints - to be assessed by the Investigator at screening.\n* Unable to abstain from nicotine (e.g. cigarettes, vape) for two hours before cognitive testing.\n* Unable to abstain from marijuana use on test day prior to test completion.\n* History of suicide attempt or behavior in previous 12 months, or risk of suicidal behavior during the study.","ALL","17 Years","30 Years",{"count":301,"type":302},150,"ESTIMATED","INTERVENTIONAL",[305,306],"PHASE1","PHASE2","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.\n\nThe main question this trial aims to answer is:\n\nCan any of the tests (biomarkers) used in this study detect changes in participants dosed with one of two different dose levels of MT1988?\n\nResearchers 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.\n\nParticipants will:\n\n* take a dose of MT1988 or placebo twice per day for 8 weeks\n* attend clinic appointments every two weeks to undertake assessments\n* report any side effects they experience to the researchers",[309],"Clinical High Risk for Psychosis (CHR)","2026-06-04",{"date":312,"type":313},"2026-06-08","ACTUAL",{"date":315,"type":313},"2026-03-03",{"date":317,"type":302},"2027-10",{"name":5,"class":6},15]