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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
Healthy adults aged 18 and above
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 95 minutes post-pet after start of pet imaging
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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I am 18 years old or older and in good health.
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I have a condition that affects my body's automatic functions and may have Parkinson's, MSA, or DLB.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Differences in FDOPA uptake across patient populations

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
Autonomic Failure Research Study Groups: [18F]F-DOPA
Autonomic Failure 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are being included in this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this study is currently recruiting patients which began on February 4th 2020 and was recently updated on April 14 2022. The trial requires 40 participants from one center of care."

Answered by AI

How is [18F]FDOPA typically employed to assist patients?

"[18F]FDOPA is regularly employed to treat Parkinson's disease and its associated complications, including the wearing off effect, carbon monoxide intoxication, and post encephalitic parkinsonism."

Answered by AI

Are participants currently being recruited for this research endeavor?

"As per clinicaltrials.gov, this research project is actively searching for participants. The trial was initially advertised on February 4th 2020 and had its most recent update recorded on April 14th 2022."

Answered by AI

How have patients responded to [18F]FDOPA as a therapeutic agent?

"Due to the fact that this is Phase 1 trial, with limited clinical data for [18F]FDOPA's safety and efficacy, our team at Power has conservatively rated its safety on a scale of 1-3 as a '1'."

Answered by AI

Is there any precedent for utilizing [18F]FDOPA in research?

"Currently, 15 [18F]FDOPA trials are operational with 4 of them in their final phase. 227 sites have been set up to run these clinical studies, a prominent one being located in Chicago, Illinois."

Answered by AI

Who else is applying?

What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I am positive that something will cure me and maybe this is the answer.
PatientReceived no prior treatments
~7 spots leftby Feb 2025