Cholinergic Enhancement of Theta
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Hepatic impairment (moderate or severe).
Renal impairment (moderate or severe).
Trial design
Design model
Crossover
Treatments tested in this trial
COBENFY KarXT (50/20 mg)
DrugPatient receives a dose of COBENFY KarXT (50/20 mg) 2 hours prior to episodic memory task.
Control
DrugPatient receives a dose of placebo 2 hours prior to episodic memory task.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: COBENFY KarXT (50/20 mg)Experimental treatment 1 intervention
Group B: ControlOther 1 intervention
Trial outcomes
Primary outcomes
1
Memory-related changes in brain electrical activity in participants from baseline at Day 1 post-intervention (approx. within 1-3 hrs)
Memory-related changes in brain electrical activity in participants from baseline at post-intervention (approx. within 1-3 hrs) is measured by comparing the Free recall memory tasks with the electrical readings collected across all bandwidths, but focusing on primarily theta power and oscillatory changes. Other changes, such as phase amplitude coupling, may also be considered.
Time frame
Baseline, at Day 1 post-intervention (approx. within 1-3 hrs)2
Memory-related changes in brain electrical activity in participants from baseline at Day 2 post-intervention (approx. within 1-3 hrs)
Memory-related changes in brain electrical activity in participants from baseline at post-intervention (approx. within 1-3 hrs) is measured by comparing the Free recall memory tasks with the electrical readings collected across all bandwidths, but focusing on primarily theta power and oscillatory changes. Other changes, such as phase amplitude coupling, may also be considered.
Time frame
Baseline, at Day 2 post-intervention (approx. within 1-3 hrs)3
Memory-related changes in brain electrical activity in participants from baseline at Day 1 post-intervention (approx. within 1-3 hrs)
Memory-related changes in brain electrical activity in participants from baseline at post-intervention (approx. within 1-3 hrs) is measured by comparing the serial recall memory tasks with the electrical readings collected across all bandwidths, but focusing on primarily thetapower and oscillatory changes. Other changes, such as phase amplitude coupling, may also be considered.
Time frame
Baseline, at Day 1 post-intervention (approx. within 1-3 hrs)4
Memory-related changes in brain electrical activity in participants from baseline at Day 2 post-intervention (approx. within 1-3 hrs)
Memory-related changes in brain electrical activity in participants from baseline at post-intervention (approx. within 1-3 hrs) is measured by comparing the serial recall memory tasks with the electrical readings collected across all bandwidths, but focusing on primarily theta power and oscillatory changes. Other changes, such as phase amplitude coupling, may also be considered.
Time frame
Baseline, at Day 2 post-intervention (approx. within 1-3 hrs)Sponsors and contacts
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Source ClinicalTrials.gov
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