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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Feb 1, 2026 to Feb 1, 2027v10
  2. Study Identification, Study Status, Oversight, Conditions, Contacts/Locations, IPDSharingv9
  3. Primary and study completion dates: Feb 1, 2025 to Feb 1, 2026v8
  4. Study Identification, Study Status, Sponsor/Collaborators, Oversight, Conditions, IPDSharingv7
  5. 2 versions Re-verified since Apr 14, 2022, no change to tracked fieldsv5-v6
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  1. Primary and study completion dates: Feb 1, 2022 to Feb 1, 2025v4
  2. Re-verified, no change to tracked fieldsv3
  3. Start date changed from estimate of Feb 1, 2020 to Feb 4, 2020v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04246437
Lead Sponsor Daniel Claassen
Conditions
(from sponsor)		 Autonomic Failure, Pure Autonomic Failure, Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies
Related terms Lewy Body Disease, Multiple System Atrophy, Parkinson Disease, Pure Autonomic Failure
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov