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NCT04246437 · ClinicalTrials.gov registry record · Phase 1
[18F]F-DOPA Imaging in Patients With Autonomic Failure
A Phase 1 study of Parkinson Disease and Multiple System Atrophy, sponsored by Daniel Claassen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT04246437: Recruiting Phase 1 study of Parkinson Disease and Multiple System Atrophy, sponsored by Daniel Claassen.
NCT04246437 is a Phase 1 study of Parkinson Disease and Multiple System Atrophy that is actively recruiting participants, run by Daniel Claassen. The registered enrollment target is 40 participants, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04246437, a Phase 1 study of Parkinson Disease and Multiple System Atrophy, is actively recruiting participants, sponsored by Daniel Claassen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Specific FDOPA uptake, Ki, will be calculated via a reference Logan plot to provide voxelwise measurements of FDOPA uptake. Mean uptake will be assessed in brain regions-of-interest in 40 participants to assess potential differences across different autonomic failure-related diseases.
Conditions Studied
Interventions
- DRUG [18F]FDOPA
- DRUG Carbidopa 200mg oral dose
- DRUG Entacapone 400mg oral dose
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-02-04 |
| Est. Completion | 2027-02-01 |
| Phase | Phase 1 |
What NCT04246437 shows while recruiting
NCT04246437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower).
The record links to 5 conditions, with Parkinson Disease appearing as the primary indexed condition, and to 3 interventions - of which [18F]FDOPA is the first listed.
NCT04246437 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04246437 about?
NCT04246437 is a clinical study titled "[18F]F-DOPA Imaging in Patients With Autonomic Failure". 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 rostr...
What is the current status of trial NCT04246437?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-02-04. Estimated completion is 2027-02-01.
What conditions does trial NCT04246437 study?
This clinical trial studies the following conditions: Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies, Autonomic Failure, Pure Autonomic Failure.
What interventions are being tested in trial NCT04246437?
The interventions under investigation include: [18F]FDOPA (DRUG), Carbidopa 200mg oral dose (DRUG), Entacapone 400mg oral dose (DRUG).
Who is sponsoring clinical trial NCT04246437?
This trial is sponsored by Daniel Claassen, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04246437 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04246437's enrollment target sits among peer trials
40 173rd of 297 higher than 109 of 297 other Parkinson Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinson Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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