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Scopolamine for Muscarinic Receptor Engagement (emo_to2 Trial)

Phase 1

Waitlist Available

Led By David Matuskey, MD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and up to 48 hours post scopolamine infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how much of a scopolamine drug reaches the brain after a single dose, in healthy people, to assess its effects.

Who is the study for?

Healthy adults aged 18-60 who can consent, read, write, and follow study directions. They must be in good health based on medical history, exams, and tests. Excluded are those with hepatitis B/C or HIV; IV drug use history; abnormal lab results or ECG; pregnant/lactating women; recent prescription meds users (with exceptions); scopolamine patch users within 14 days; participants in other trials recently involving drugs or radiotracers; current smokers/nicotine users; substance abuse history within 2 years; positive drug screening.

What is being tested?

The trial is testing how the body's M1 Muscarinic Receptors in the brain respond to different doses of scopolamine given intravenously. It uses a special imaging tracer called [11C]EMO ([11C]LSN3172176) during PET and MRI scans to measure this response in healthy volunteers.

What are the potential side effects?

Potential side effects from scopolamine may include dry mouth, blurred vision, dizziness, confusion, difficulty urinating. The radiotracer used for imaging might cause temporary discomfort at the injection site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and up to 48 hours post scopolamine infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and up to 48 hours post scopolamine infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 48 hours post scopolamine infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in brain muscarinic receptor occupancy with [11C]LSN3172176 PET

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Scopolamine low doseExperimental Treatment2 Interventions

The target occupancy (TO) of scopolamine at M1 will be evaluated using the radiotracer \[11C\]EMO and positron emission tomography (PET). TO will be measured following a 15-minute IV infusion of 2.0 μg/kg scopolamine in 0-2 anticipated participants.

Group II: Scopolamine high doseExperimental Treatment2 Interventions

The target occupancy (TO) of scopolamine at M1 will be evaluated using the radiotracer \[11C\]EMO and positron emission tomography (PET). TO will be measured following a 15-minute IV infusion of 4.0 μg/kg scopolamine in 4-6 anticipated participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Scopolamine

2011

Completed Phase 4

~27700

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