Tests Cobenfy KarXT effects on memory brain activity in people with epilepsy
Tests Cobenfy KarXT against a control on memory and brain activity in epilepsy patients.
Plain-language title generated from the registry record
Registry title: Cholinergic Enhancement of Theta
Key facts
- Where
- Dallas, United StatesSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07228338, who can take part
Where in United States
- University of Texas Southwestern Medical CenterDallas, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Texas Southwestern Medical Center
- Trial code
- NCT07228338
- Record updated
- 29 September 2026
- Original description
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.Read full original descriptionShow less
Muscarinic Agonist Modulation of Memory Processing Oscillatory Activity
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.
The 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.
Participants will complete two treatment arms. One of these will be with the drug, and the other will be control session. Participants will not be blinded to the study condition. Patients will complete a verbal serial recall and/or 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.
Researchers 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.
Inclusion: Age 18 - 75 years, all races/ethnicities, and both genders are eligible; 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; Able to read, understand, and provide written, dated informed consent prior to screening; In good general health, aside from a history of epilepsy, as ascertained by medical history, physical examination (PE), clinical laboratory evaluations, and ECG.
Exclusion: Strong Inhibitors of CYP2D6 such as fluoxetine, paroxetine, bupropion, terbinafine; Drugs Eliminated by Active Tubular Secretion; Antimuscarinic Drugs such as diphenhydramine, benztropine, oxybutynin; Hepatic impairment (moderate or severe); Renal impairment (moderate or severe); History of hypersensitivity to COBENFY or trospium chloride (angioedema risks); Biliary Disease (symptomatic gallstones, gallbladder disorders, pancreatitis); 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; 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; Clinically significant bladder outlet obstruction or incomplete bladder emptying, such as patients with prostatic hyperplasia (BPH), diabetic cystopathy, pre-existing urinary retention; Untreated narrow-angle glaucoma; Sensitive Substrates of CYP3A4 such as buspirone, eletriptan; Narrow Therapeutic Index Substrates of P-glycoprotein such as digoxin, colchicine, apixaban.