NCT06014385

PET and MRI Imaging With Scopolamine at the Muscarinic M1 Receptor

A Trial to Evaluate Target Occupancy of Scopolamine at the Muscarinic M1 Receptor

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the target occupancy (TO) of scopolamine at M1 Muscarinic Receptors in the brain after single I.V. doses of scopolamine, in healthy control subjects, using the radiotracer \[11C\]EMO (also known as \[11C\]LSN3172176).

Detailed description

Each participant will complete a baseline (pre-dose) PET scan and a post-dose PET scan, following a 15-minute IV infusion of scopolamine. Each participant will also complete a magnetic resonance imaging (MRI) scan of the brain. The timing of the post scopolamine \[11C\] EMO PET scan tracer injection could occur 15 minutes to 48 hours after the scopolamine infusion has been completed. In this study, the post scopolamine \[11C\] EMO PET scan tracer injection should be given 4 hours (± 5 minutes) after the scopolamine infusion of 4.0 μg/kg in up to 2 subjects. The data from those 2 subjects will be reviewed to determine the timepoint for tracer injection for the post scopolamine \[11C\] EMO PET scan in the next 2 subjects (e.g., tracer injection at 24-hour or 1-hour post-dose). If the baseline and post scopolamine PET scans are obtained on the same day, the scopolamine infusion should be started after the acquisition of the baseline PET scan has been completed. The data from the first 4 subjects will be reviewed to determine the dose level and timepoint for tracer injection in the last 2 subjects. . At least 2 hours should elapse between injections of \[11C\] EMO to allow for clearance of the tracer signal from the baseline scan and the injection of \[11C\] EMO for a post scopolamine PET scan should not be given during a scopolamine infusion. Participants will complete at least 2 visits and up to 4.

Conditions

• Muscarinic Receptor Occupancy

Interventions

Type	Name	Description
DRUG	Scopolamine	TO will be measured following a 15-minute IV infusion of up to 2 dose levels of scopolamine: 4.0 μg/kg and 2.0 μg/kg
RADIATION	[11C]EMO ([11C]LSN3172176)	A radiotracer specific for imaging M1 receptors. For each PET scan, up to 20 mCi of \[11C\]EMO i.v. will be administered twice, at baseline and post dosing with scopolamine.

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-08-28
• Last updated: 2025-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study