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[18F]FDOPA Imaging for Parkinson's Disease

Phase 1
Recruiting
Research Sponsored by Daniel Claassen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with a diagnosis of pure autonomic failure
Be older than 18 years old
Must not have
Minors (younger than 18 years)
Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 95 minutes post-pet after start of pet imaging
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a biomarker that may predict which patients with Pure Autonomic Failure (PAF) will convert to Parkinson's disease (PD), Multiple System Atrophy (MSA), or Dementia with Lewy Bodies (DLB). The biomarker is related to the neurotransmitter dopamine.

Who is the study for?
This trial is for adults with a diagnosis of pure autonomic failure or those who may have Parkinson's Disease (PD), Multiple System Atrophy (MSA), or Dementia with Lewy Bodies (DLB). Healthy adults can also participate. Excluded are pregnant women, minors, prisoners, individuals with certain bioimplants, mental disabilities preventing informed consent, and those unable to follow the study protocol.
What is being tested?
[18F]FDOPA PET imaging is being tested to observe dopamine production in the brainstem and related areas. The goal is to distinguish between PD, MSA, DLB in patients with autonomic failure. Participants will take Carbidopa and Entacapone orally before imaging to enhance the test's accuracy.
What are the potential side effects?
Potential side effects from Carbidopa include nausea and dizziness; Entacapone may cause diarrhea or abdominal pain. The [18F]FDOPA injection used for PET scans has minimal side effects but might cause slight discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with pure autonomic failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.
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I am able to understand and give consent for my treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~95 minutes post-pet after start of pet imaging
This trial's timeline: 3 weeks for screening, Varies for treatment, and 95 minutes post-pet after start of pet imaging for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differences in FDOPA uptake across patient populations

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: [18F]F-DOPAExperimental Treatment3 Interventions
All patients will receive \[18F\]F-DOPA for PET imaging to measure pre-synaptic dopamine in the brain.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Daniel ClaassenLead Sponsor

Media Library

[18F]FDOPA Clinical Trial Eligibility Overview. Trial Name: NCT04246437 — Phase 1
Dementia Research Study Groups: [18F]F-DOPA
Dementia Clinical Trial 2023: [18F]FDOPA Highlights & Side Effects. Trial Name: NCT04246437 — Phase 1
[18F]FDOPA 2023 Treatment Timeline for Medical Study. Trial Name: NCT04246437 — Phase 1
~1 spots leftby Feb 2025
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