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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 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.

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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.

Conditions Studied

Parkinson Disease Multiple System Atrophy Dementia With Lewy Bodies Autonomic Failure Pure Autonomic Failure

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

FieldValue
Enrollment Target 40 participants
Start Date 2020-02-04
Est. Completion 2027-02-01
Phase Phase 1

Sponsor

Daniel Claassen

1 total trials

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What the Registry Record Tells You About NCT04246437

The ClinicalTrials.gov registry entry for NCT04246437 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 5,326-participant average among 297 other Parkinson Disease trials with a reported enrollment target (99% lower). The listed sponsor is Daniel Claassen, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.