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NCT07228338Not yet recruitingEarly phase 1

Cholinergic Enhancement of Theta

Muscarinic Agonist Modulation of Memory Processing Oscillatory Activity

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
50 (estimated)
First submitted
12 Nov 2025
Start date
1 Dec 2026
Primary completion date
31 Dec 2031
Lead sponsor
University of Texas Southwestern Medical Center
Diseases
Epilepsy
NCT number
NCT07228338

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 50
  • From 1 Dec 2026 to the primary completion date, 31 Dec 2031
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Strong Inhibitors of CYP2D6 such as fluoxetine, paroxetine, bupropion, terbinafine.
  • Drugs Eliminated by Active Tubular Secretion.
  • Antimuscarinic Drugs such as diphenhydramine, benztropine, oxybutynin.

Other illness

  • 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).

Other

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.