[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611000":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":45,"responsibleParty":68,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":28,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":28,"enrollmentInfo":85,"targetDuration":28,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":28,"overallStatus":48,"whyStopped":28,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1 Placebo","EXPERIMENTAL","Participants randomized into one group 1placebo. Placebo will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.",[13],"Drug: AV-001 or Placebo Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Group 2: AV-001 low dose (12.5μg\u002Fkg)","Participants randomized into group 2 will receive AV-001 low dose. AV-001 low dose will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Group 3: AV-001 High Dose (25μg\u002Fkg)","Participants randomized into group 3 will receive AV-001 high dose. AV-001 high dose will be administered 60 minutes prior to hemodialysis initiation, 3 x over a one-week treatment period.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","AV-001 or Placebo Injection","AV-001 or Placebo administered via IV bolus injection.",[9,15,19],null,[30],{"name":31,"affiliation":32,"role":33},"Christopher W McIntyre, MD\u002FPhD","London Health Science Centre","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Jarrin D Penny, PhD, RN","CONTACT","519-685-8500","58765","jarrin.penny@lhsc.on.ca",{"name":42,"role":37,"phone":38,"phoneExt":43,"email":44},"Kathy Koyle","56214","kathleen.koyle@lhsc.on.ca",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"London Health Sciences Centre","RECRUITING","London","Ontario","N6A 5W9","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-81.23304,42.98339,{"lat":58,"lon":57},[61,64,66],{"name":62,"role":37,"phone":38,"phoneExt":63,"email":40},"Jarrin Penny, PhD, RN","x 58765",{"name":42,"role":37,"phone":38,"phoneExt":65,"email":44},"x 56214",{"name":67,"role":33,"phone":28,"phoneExt":28,"email":28},"Christopher McIntyre, MBBS DM",{"type":33,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":71,"oldNameTitle":28,"oldOrganization":28},"Chris McIntyre","MBBS DM","London Health Sciences Centre Research Institute",[73],{"name":74,"class":75},"Vasomune Therapeutics, Inc.","INDUSTRY","100611000","phase-2-study-to-evaluate-the-effects-of-av-001-on-hd-induced-brain-injury-100611000",false,"NCT07234890","Study to Evaluate the Effects of AV-001 on HD-induced Brain Injury.","A Randomized, Double-Blind, Placebo-Controlled Phase 2 Exploratory Study to Evaluate the Neuroprotective Effects of AV-001 on Hemodialysis-induced Brain Injury Via Cerebrovascular Stabilization in Chronic Hemodialysis Patients","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Male and non-pregnant female patients (\\>18 years old)\n* HD for ≥ 3 months\n* Thrice weekly HD schedule\n\nExclusion Criteria:\n\n* HD \\\u003C90 days\n* Contraindication to MRI\n* Established severe cognitive impairment (Montreal Cognitive Assessment test (MoCA) \\\u003C18 or formal diagnosis of dementia)\n* Previous clinical stroke\n* Pregnancy, breastfeeding, or intending pregnancy\n* Intradialytic hypotension event (defined as: drop in SBP ≥40mmHg + symptoms + intervention) in previous month as evidenced by HD record","ALL","18 Years",{"count":86,"type":87},60,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","Cognitive decline is increasingly recognized among patients receiving maintenance hemodialysis (HD). This can include trouble remembering, slower thinking or mentally feeling foggy.\n\nThis research is being done to determine if a new medication (AV-001) can protect the brain from injury caused by hemodialysis by strengthening blood vessels in the brain and reducing inflammation.\n\nIf successful, this research could lead to better protection for the brains of people undergoing regular dialysis, potentially reducing the risk of cognitive decline and stroke.",[93],"Hemodialysis","2026-04-15",{"date":96,"type":97},"2026-04-17","ACTUAL",{"date":99,"type":97},"2025-12-16",{"date":101,"type":87},"2027-12-31",{"name":71,"class":6},1]