20 Participants NeededMy employer runs this trial

18F-mFBG Imaging for Lewy Body Dementia

(IRP101-231 Trial)

RC
CT
Overseen ByClinical Trials Manager
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 2 study evaluating the positron-emitting radiopharmaceutical 18F-mFBG as an imaging agent for quantification of the effect of neurodegenerative diseases on myocardial sympathetic innervation. Effectiveness of 18F-mFBG imaging of the heart will be judged in terms of the quantitative difference between results for subjects with Lewy body and non-Lewy body neurologic disease as compared to historical data for healthy control subjects.

Who Is on the Research Team?

JB

Juan B Toledo, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 or older and agree to follow the study rules.
I am not pregnant, and I cannot become pregnant due to surgery, menopause, or I am using birth control.
I have a neurological condition that is not Parkinson's or dementia with Lewy bodies.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • 18F-MFBG

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Cohort 1: Known or presumed Lewy body disease (Parkinson's disease (PD) and Lewy body dementia (LBD)Active Control1 Intervention
Group II: Cohort 2: neurologic disease due to non-Lewy body pathology.Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC)

Lead Sponsor

Trials
3
Recruited
60+