[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611004":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":41,"responsibleParty":136,"collaborators":25,"id":138,"slug":25,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":25,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":25,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":25,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RO7812653","EXPERIMENTAL","Participants will receive a dose of RO7812653",[13],"Drug: RO7812653",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive a dose of placebo",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will receive RO7812653 as per the schedule in the protocol",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Participants will receive placebo as per the schedule in the protocol",[15],[30],{"name":31,"affiliation":5,"role":32},"Clinical Trials","STUDY_DIRECTOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Reference Study ID Number: BP45770 https:\u002F\u002Fforpatients.roche.com\u002F","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":40,"role":36,"phone":25,"phoneExt":25,"email":25},"Fastest response: use the inquiry form. No email attachments. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",[42,55,66,76,85,90,99,110,120,130],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":25},"Montreal Neurological Institute Clinical Research Unit","RECRUITING","Montreal","Quebec","H3A 2B4","Canada",{"type":50,"coordinates":51},"Point",[52,53],-73.58781,45.50884,{"lat":53,"lon":52},{"facility":56,"status":44,"city":57,"state":58,"zip":59,"country":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"Brain Research Center Amsterdam","Amsterdam","North Holland","1081 HV","Netherlands",{"type":50,"coordinates":62},[63,64],4.88969,52.37403,{"lat":64,"lon":63},{"facility":67,"status":44,"city":68,"state":25,"zip":69,"country":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":25},"Hospital de la Santa Creu i Sant Pau","Barcelona","08025","Spain",{"type":50,"coordinates":72},[73,74],2.15899,41.38879,{"lat":74,"lon":73},{"facility":77,"status":44,"city":78,"state":25,"zip":79,"country":70,"cosmosGeoPoint":80,"geoPoint":84,"contacts":25},"Hospital Universitario Reina Sofia","Córdoba","14004",{"type":50,"coordinates":81},[82,83],-4.77275,37.89155,{"lat":83,"lon":82},{"facility":86,"status":44,"city":87,"state":25,"zip":88,"country":89,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"Sahlgrenska Universitetssjukhuset","Mlndal","43180","Sweden",{"facility":91,"status":44,"city":92,"state":25,"zip":93,"country":89,"cosmosGeoPoint":94,"geoPoint":98,"contacts":25},"Karolinska Universitetssjukhuset","Solna","171 76",{"type":50,"coordinates":95},[96,97],18.00086,59.36004,{"lat":97,"lon":96},{"facility":100,"status":44,"city":101,"state":102,"zip":103,"country":104,"cosmosGeoPoint":105,"geoPoint":109,"contacts":25},"Institute of Psychiatry, Psychology and Neuroscience;Department of Old Age Psychiatry","London","Greater London","SE5 8AF","United Kingdom",{"type":50,"coordinates":106},[107,108],-0.12574,51.50853,{"lat":108,"lon":107},{"facility":111,"status":44,"city":112,"state":113,"zip":114,"country":104,"cosmosGeoPoint":115,"geoPoint":119,"contacts":25},"Southampton General Hospital","Southampton","Hampshire","SO16 6YD",{"type":50,"coordinates":116},[117,118],-1.40428,50.90395,{"lat":118,"lon":117},{"facility":121,"status":44,"city":122,"state":123,"zip":124,"country":104,"cosmosGeoPoint":125,"geoPoint":129,"contacts":25},"Queen Elizabeth Hospital","Glasgow","Strathclyde","G21 3UW",{"type":50,"coordinates":126},[127,128],-4.25763,55.86515,{"lat":128,"lon":127},{"facility":131,"status":44,"city":101,"state":25,"zip":132,"country":104,"cosmosGeoPoint":133,"geoPoint":135,"contacts":25},"National Hospital For Neurology and Neurosurgery","WC1N 3BG",{"type":50,"coordinates":134},[107,108],{"lat":108,"lon":107},{"type":137,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100611004",false,"NCT07234942","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer's Disease","Inclusion Criteria:\n\n* Probable AD dementia (consistent with National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia) \\[McKhann et al 2011\\] or Mild Cognitive Impairment (MCI) due to AD (consistent with the NIA-AA core clinical criteria for mild cognitive impairment due to AD) \\[Albert et al 2011\\]).\n* Willingness and ability to complete all aspects of the study. The participant should be capable of completing assessments either alone or with the help of the study partner.\n* Fluency in the language of the tests used at the study site.\n* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted).\n* If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 8 weeks prior to screening and until randomization is required.\n* Agreement not to participate in other research studies for the duration of this study.\n\nExclusion Criteria:\n\n* Any medical history or evidence of a condition other than AD that may affect cognition.\n* Presence of any significant cerebral abnormalities that would contraindicate lumbar puncture, as assessed on MRI\n* Any other significant cerebral abnormalities that the Investigator considers clinically significant\n* History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder.'\n* Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological medical conditions which are not stable and adequately controlled or which in the opinion of the investigator could affect the subject's safety in the study or interfere with the study assessments","ALL","50 Years","75 Years",{"count":148,"type":149},50,"ESTIMATED","INTERVENTIONAL",[152],"PHASE1","This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.",[155],"Alzheimer's Disease","2026-06-28",{"date":158,"type":159},"2026-06-30","ACTUAL",{"date":161,"type":159},"2026-01-27",{"date":163,"type":149},"2030-03-05",{"name":5,"class":6},10]