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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
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,967 Total Patients Enrolled
Yale UniversityLead Sponsor
1,927 Previous Clinical Trials
3,031,726 Total Patients Enrolled
David Matuskey, MDPrincipal InvestigatorYale University
1 Previous Clinical Trials
20 Total Patients Enrolled