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Cholinergic Enhancement of Theta

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started2026-12
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Oct 2031 → Dec 2031
See other at-risk trials from University of Texas Southwestern Medical Center

Amendment history

2026-09-30
notable
Primary completion pushed: 2031-10 → 2031-12
Completion pushed: 2031-10 → 2031-12
Interventions modified
2026-04-08
minor
Study Status v2
Primary completion date2031-01→2031-10
Completion date2031-01→2031-10
Start date2026-01→2026-10
2025-11-20
minor
Study Status, Outcome Measures v1
Re-verified, no change to tracked fields
2025-11-12
minor
Original filing
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.
Trial Details
NCT Number NCT07228338
Lead Sponsor University of Texas Southwestern Medical Center
Conditions Epilepsy, Seizures, Cognitive Impairment, Mild, Memory Disorder, Memory Loss
Enrollment 50 participants
Start Date 2026-12
Primary Completion 2031-12 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-29