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NCT06303921 · ClinicalTrials.gov registry record · Early Phase 1

Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503

A Early Phase 1 study of Tauopathies, sponsored by University of Pennsylvania.

Recruiting
Registry status
Early Phase 1
Development phase
70
Enrollment target
3
Study locations

NCT06303921: Recruiting Early Phase 1 study of Tauopathies, sponsored by University of Pennsylvania.

NCT06303921 is a Early Phase 1 study of Tauopathies that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 70 participants, roughly in line with the 70-participant average among 5 other Tauopathies trials with a reported enrollment target. The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06303921, a Early Phase 1 study of Tauopathies, is actively recruiting participants, sponsored by University of Pennsylvania.

RECRUITING
Registry status
Early Phase 1
Development phase
70 participants
Enrollment target
3
Study locations

Study Summary

The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participants with PD versus participants with multiple system atrophy (MSA) and progressive supranuclear palsy (PSP), as well as non-Parkinsonism volunteers. This multicenter project funded by an NIH U19 grant, is centered at U Pennsylvania (Penn, Grant PI: Robert Mach) in collaboration with U Pittsburgh (Pitt) (non-clinical site) Yale U, U of California at San Francisco (UCSF) and Washington University in St. Louis (WU). The University of Pennsylvania will act as the sIRB for this multi-center human subjects project and participants will be recruited from all sites.

Conditions Studied

Interventions

  • BEHAVIORAL Neurological assessments
  • DRUG 11C-M503 PET
  • DIAGNOSTIC_TEST Brain MRI
  • DIAGNOSTIC_TEST Amyloid PET

Study Locations (3)

Connecticut

  • Yale New Haven Hospital - New Haven

Missouri

  • Washington University in St. Louis - St Louis

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2024-02-16
Est. Completion 2029-02
Phase Early Phase 1

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT06303921

The ClinicalTrials.gov registry entry for NCT06303921 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 70-participant average among 5 other Tauopathies trials with a reported enrollment target. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Tauopathies appearing as the primary indexed condition, and to 4 interventions - of which Neurological assessments is the first listed.

NCT06303921 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Connecticut, Missouri, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT06303921 about?

NCT06303921 is a clinical study titled "Study of Biodistribution, Metabolism, Excretion and Brain Uptake11C-M503". The current protocol is to determine the biodistribution, metabolism, excretion and brain uptake of 11C-M503. The goal of this radiotracer is to quantify alpha-synuclein that is abnormally deposited in the brain of people with Parkinson's disease (PD). Investigators will compare uptake in participan...

What is the current status of trial NCT06303921?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 70 participants. The study started on 2024-02-16. Estimated completion is 2029-02.

What conditions does trial NCT06303921 study?

This clinical trial studies the following conditions: Tauopathies.

What interventions are being tested in trial NCT06303921?

The interventions under investigation include: Neurological assessments (BEHAVIORAL), 11C-M503 PET (DRUG), Brain MRI (DIAGNOSTIC_TEST), Amyloid PET (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT06303921?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06303921 being conducted?

This trial has 3 study locations across Connecticut, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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