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Study identifier: NCT04246437 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Autonomic Failure · Pure Autonomic Failure · Parkinson Disease  ·  Sponsor: Daniel Claassen

PhasePhase 1
Planned participants40
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

About this study

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 stu…

This description comes directly from the study's public registry record.

Talk to the study team

Daniel O Claassen, MD, MS  ·  615-936-1007  ·  daniel.claassen@vumc.org

Kaitlyn O'Rourke, MS  ·  katie.orourke@vumc.org

Always discuss trial participation with your own doctor first.

Locations (1)

Vanderbilt University Medical CenterNashville, Tennessee, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04246437