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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
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 belowSelect...
I have been diagnosed with pure autonomic failure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I am able to understand and give consent for my treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 95 minutes post-pet after start of pet imaging
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~95 minutes post-pet after start of pet imaging
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.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Daniel ClaassenLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with pure autonomic failure.Medical examination confirming the diagnosis.You have any kind of metal implant that could move because of the magnetic field.I am under 18 years old.You cannot be pregnant because we don't know how the strong MRI machine could affect the baby.I am 18 years old or older and in good health.You have metal clips in your brain to treat an aneurysm.I am able to understand and give consent for my treatment.I have a condition that affects my body's automatic functions and may have Parkinson's, MSA, or DLB.You have metal fragments in your body, for example, from a war injury or from working with metal.
Research Study Groups:
This trial has the following groups:- Group 1: [18F]F-DOPA
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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