[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610496":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":55,"collaborators":25,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":25,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":82,"overallStatus":86,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"COBENFY KarXT (50\u002F20 mg)","EXPERIMENTAL","Subjects will receive a dose of COBENFY KarXT (50\u002F20 mg). Approximately 2 hours minutes after administration, the participant will then complete an episodic memory task session. If the patient completed the sham session already, this session will take place minimum of 24 hours following the initial session, or at least four half-lives after the first session.",[13],"Drug: COBENFY KarXT (50\u002F20 mg)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Subjects will receive a placebo. Approximately 2 hours minutes after administration, the participant will then complete an episodic memory task session. If the patient completed the COBENFY KarXT session already, this session will take place minimum of 24 hours following the initial session, or at least four half-lives after the first session.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Patient receives a dose of COBENFY KarXT (50\u002F20 mg) 2 hours prior to episodic memory task.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Patient receives a dose of placebo 2 hours prior to episodic memory task.",[15],[30],{"name":31,"affiliation":5,"role":32},"Bradley C Lega, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","214-648-7816","Bradley.Lega@UTSouthwestern.edu",[39],{"facility":5,"status":25,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Dallas","Texas","75390","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-96.80667,32.78306,{"lat":49,"lon":48},[52],{"name":31,"role":35,"phone":53,"phoneExt":25,"email":54},"713-834-2497","Bradley.Lega@UTSouthwesthern.edu",{"type":32,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Bradley Lega","Professor - Neurological Surgery","100610496","early-phase-1-cholinergic-enhancement-of-theta-100610496",false,"NCT07228338","Cholinergic Enhancement of Theta","Muscarinic Agonist Modulation of Memory Processing Oscillatory Activity","Inclusion Criteria:\n\n1. Age 18 - 75 years, all races\u002Fethnicities, and both genders are eligible.\n2. Candidates for pre-operative evaluation using stereo intracranial electrodes and admission to the Epilepsy Monitoring Unit (EMU) as determined independently by the patient's treating physician as part of the patient's routine medical care.\n3. Able to read, understand, and provide written, dated informed consent prior to screening.\n4. In good general health, aside from a history of epilepsy, as ascertained by medical history, physical examination (PE), clinical laboratory evaluations, and ECG.\n\nExclusion Criteria:\n\n1. Has a clinically significant abnormality on the screening physical examination that might affect safety, study participation, or confound interpretation of study results according to the study physician.\n2. Female that is pregnant, breastfeeding, or has a positive pregnancy test at screening or baseline. We note that pregnant patients are excluded from undergoing iEEG.\n3. Hepatic impairment (moderate or severe).\n4. Renal impairment (moderate or severe).\n5. Clinically significant bladder outlet obstruction or incomplete bladder emptying, such as patients with prostatic hyperplasia (BPH), diabetic cystopathy, pre-existing urinary retention.\n6. History of hypersensitivity to COBENFY or trospium chloride (angioedema risks).\n7. Untreated narrow-angle glaucoma.\n8. Biliary Disease (symptomatic gallstones, gallbladder disorders, pancreatitis).\n9. Strong Inhibitors of CYP2D6 such as fluoxetine, paroxetine, bupropion, terbinafine.\n10. Sensitive Substrates of CYP3A4 such as buspirone, eletriptan.\n11. Narrow Therapeutic Index Substrates of P-glycoprotein such as digoxin, colchicine, apixaban.\n12. Drugs Eliminated by Active Tubular Secretion.\n13. Antimuscarinic Drugs such as diphenhydramine, benztropine, oxybutynin.",true,"ALL","18 Years","75 Years",{"count":70,"type":71},50,"ESTIMATED","INTERVENTIONAL",[74],"EARLY_PHASE1","The goal of this study is to learn about the effects of Cobenfy KarXT (xanomeline and trospium chloride) on episodic memory processing, including specific effects on areas of the brain involved in memory and changes it may have on brain activity. The investigators will do this by testing epileptic patients who are already undergoing intracranial surgery for seizure monitoring, and measuring the activity from the brain areas being assessed.\n\nThe main questions it aims to answer are 1) whether Cobenfy KarXT changes memory activity based on its agonist effect on muscarinic receptors and acetylcholine, and 2) what the nature of these brain activity changes are. This work builds on previous experiments evaluating cholinergic antagonists.\n\nParticipants will complete two treatment arms. One of these will be with the drug, and the other will be with a placebo pill, so that the participants are unaware which session the actual drug has been received. Patients will complete a verbal serial recall and\u002For associative recognition task each of the two days. An anesthesiologist or patient nurse will administer either the drug or the placebo at a critical point which addresses both of the research questions.\n\nResearchers will compare the brain activity between the two treatment arms to determine what brain activity changes, and whether there is an additional behavioral effect on memory.",[77,78,79,80,81],"Epilepsy","Seizures","Cognitive Impairment, Mild","Memory Disorder","Memory Loss",[83,84,85],"oscillatory changest","cholinergic agonist","muscarinic agonist","NOT_YET_RECRUITING","2026-04-08",{"date":89,"type":90},"2026-04-09","ACTUAL",{"date":92,"type":71},"2026-10",{"date":94,"type":71},"2031-10",{"name":5,"class":6},1]