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RecruitingPhase 1

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET scans with a tracer called [18F]F-DOPA to look for changes in how the brain makes dopamine, a chemical messenger. It may help predict whether pure autonomic failure will develop into Parkinson’s disease or related brain diseases. The study includes people with autonomic failure, which affects automatic body functions, and healthy adults.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have pure autonomic failure, a disorder of nerves that control automatic body functions.
  • Or have autonomic failure with possible Parkinson’s disease, multiple system atrophy, or dementia with Lewy bodies.
  • Or be a healthy adult age 18 or older.
  • Have a medical exam that confirms your health or disease group.

Who can't join

  • Are younger than 18 or pregnant.
  • Have an implanted device powered by mechanical, electronic, or magnetic means, such as a pacemaker or hearing implant.
  • Have an implanted device made of metal that a magnet could move, or clips used to treat a bulging blood vessel in the brain.
  • May have metal fragments in your body, or work as a metal worker or machinist and could have metal near your eyes.
  • Cannot give informed written consent, meaning you cannot understand the study and agree in writing to join.
  • Cannot follow the study steps or communicate with the researcher.
  • Have confusion, limited thinking ability, a mental disability, or a mental health condition that prevents informed consent.
  • Are a prisoner.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Patients with a diagnosis if pure autonomic failure 2. Patients with autonomic failure and possible PD, MSA, or DLB 3. Healthy adults aged 18 and above 4. Clinical exam confirming clinical designation Exclusion Criteria: * 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 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. * Minors (younger than 18 years) Also excluded are subjects incapable of giving informed written consent: * Subjects who cannot adhere to the experimental protocols for any reason, or have an inability to communicate with the researcher. * Subjects who have limited mental ability to give informed consent, mentally retarded, altered mental status, mental disability, confusion, or psychiatric disorders. * Prisoners

Study sites (1)

TN