Cholinergic Enhancement of Theta

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT07228338
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cognitive Impairment, Mild
  • Epilepsy
  • Memory Disorder
  • Memory Loss
  • Seizures

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • COBENFY KarXT (50/20 mg) — DRUG
    Patient receives a dose of COBENFY KarXT (50/20 mg) 2 hours prior to episodic memory task.
  • Placebo — DRUG
    Patient receives a dose of placebo 2 hours prior to episodic memory task.

Study Details

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 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/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.

Key Dates

Start date
Oct 31, 2026
Status verified
Apr 2026
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: COBENFY KarXT (50/20 mg)
    Subjects will receive a dose of COBENFY KarXT (50/20 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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Memory-related changes in brain electrical activity in participants from baseline at Day 1 post-intervention (approx. within 1-3 hrs) [ Time Frame: Baseline, at Day 1 post-intervention (approx. within 1-3 hrs) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
Bradley C Lega, MD
[email protected]
713-834-2497

Find similar trials in Dallas, TX

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
University of Texas Southwestern Medical Center· Dallas, TX

Related Studies