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Taking people in United StatesPhase 1

Brain PET Scan Using F-DOPA in People With Autonomic Failure

Tests a radioactive brain scan in adults with autonomic failure and related brain diseases.

Key facts

Who runs it
Daniel Claassen
Where
Nashville, United StatesSee the site
Trial code
Registry title
[18F]F-DOPA Imaging in Patients With Autonomic Failure
Status
Recruiting
Phase
Phase 1
People taking part
40 people, planned
Started
4 Feb 2020
Expected to end
1 Feb 2027
Type of study
Interventional
Treatments tested
  • [18F]FDOPA
  • Carbidopa 200mg oral dose
  • Entacapone 400mg oral dose
Record updated
16 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with pure autonomic failure, or autonomic failure with possible Parkinson's disease, multiple system atrophy or dementia with Lewy bodies, and also healthy adults.

Age
18 years and older
Sex
All sexes can join.
Disease stage
Pure autonomic failure, or autonomic failure with possible PD, MSA or DLB, confirmed by a clinical exam. Healthy adults can also join.

Main reasons for not taking part

  • Bioimplants such as pacemakers, cochlear implants or neurostimulators
  • Ferromagnetic implants or cerebral aneurysm clips
  • Possible metal fragments in the body, such as shrapnel, or work as a metal worker
  • Pregnancy
  • Cannot give informed written consent, or is a prisoner

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Patients with a diagnosis if pure autonomic failure
  • Patients with autonomic failure and possible PD, MSA, or DLB
  • Healthy adults aged 18 and above
  • Clinical exam confirming clinical designation

Who cannot take part

  • Subjects who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.), because such devices may be displaced or malfunction
  • Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders
  • Minors (younger than 18 years); Also excluded are subjects incapable of giving informed written consent:
  • Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced
  • Subjects who have cerebral aneurysm clips
  • Subjects who may have shrapnel imbedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes)
  • Subjects who are pregnant, because the effects of high field MRI on fetuses are not yet known
  • Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher
  • Prisoners

Where in United States

  • Vanderbilt University Medical CenterNashville, United StatesContact: Daniel O Claassen, MD, MSTaking people

About the trial

What the trial wants to find out

Alpha-synucleinopathies refer to age-related neurodegenerative and dementing disorders, characterized by the accumulation of alpha-synuclein in neurons and/or glia. The anatomical location of alpha-synuclein inclusions (Lewy Bodies) and the pattern of progressive neuronal death (e.g. caudal to rostral brainstem) give rise to distinct neurological phenotypes, including Parkinson's disease (PD), Multiple System Atrophy (MSA), Dementia with Lewy Bodies (DLB). Common to these disorders are the involvement of the central and peripheral autonomic nervous system, where Pure Autonomic Failure (PAF) is thought (a) to be restricted to the peripheral autonomic system, and (b) a clinical risk factor for the development of a central synucleinopathy, and (c) an ideal model to assess biomarkers that predict phenoconversion to PD, MSA, or DLB. Such biomarkers would aid in clinical trial inclusion criteria to ensure assessments of disease- modifying strategies to, delay, or halt, the neurodegenerative process. One of these biomarkers may be related to the neurotransmitter dopamine (DA) and related changes in the substantia nigra (SN) and brainstem. [18F]F-DOPA is a radiolabeled substrate for aromatic amino acid decarboxylase (AAADC), an enzyme involved in the production of dopamine. Use of this radiolabeled substrate in positron emission tomography (PET) may provide insight to changes in monoamine production and how they relate to specific phenoconversions in PAF patients. Overall, this study aims to identify changes in dopamine production in key regions including the SN, locus coeruleus, and brainstem to distinguish between patients with PD, MSA, and DLB, which may provide vital information to predict conversion from peripheral to central nervous system disease.

The group in the trial

  • [18F]F-DOPATreatment being tested

    All patients will receive \[18F\]F-DOPA for PET imaging to measure pre-synaptic dopamine in the brain.

    Treatment: [18F]FDOPA, Carbidopa 200mg oral dose, and Entacapone 400mg oral dose

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
[18F]F-DOPA Imaging in Patients With Autonomic Failure
Plain-language title
Brain PET Scan Using F-DOPA in People With Autonomic FailureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
16 March 2026