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

Primary Purpose

Autonomic Failure, Pure Autonomic Failure, Parkinson Disease

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]FDOPA
Carbidopa 200mg oral dose
Entacapone 400mg oral dose
Sponsored by
Daniel Claassen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Autonomic Failure focused on measuring FDOPA, PET

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vanderbilt University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]F-DOPA

Arm Description

All patients will receive [18F]F-DOPA for PET imaging to measure pre-synaptic dopamine in the brain.

Outcomes

Primary Outcome Measures

Differences in FDOPA uptake across patient populations
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.

Secondary Outcome Measures

Full Information

First Posted
January 25, 2020
Last Updated
September 6, 2023
Sponsor
Daniel Claassen
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1. Study Identification

Unique Protocol Identification Number
NCT04246437
Brief Title
[18F]F-DOPA Imaging in Patients With Autonomic Failure
Official Title
[18F]F-DOPA Imaging in Patients With Autonomic Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Daniel Claassen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autonomic Failure, Pure Autonomic Failure, Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies
Keywords
FDOPA, PET

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
[18F]F-DOPA
Arm Type
Experimental
Arm Description
All patients will receive [18F]F-DOPA for PET imaging to measure pre-synaptic dopamine in the brain.
Intervention Type
Drug
Intervention Name(s)
[18F]FDOPA
Intervention Description
Patients will receive a 3-D emission scan following a 6-8 mCi slow bolus injection of [18F]FDOPA over a 30 second period. Serial scans are started simultaneously with the bolus injection of radiotracer and are obtained for approximately 95 minutes.
Intervention Type
Drug
Intervention Name(s)
Carbidopa 200mg oral dose
Other Intervention Name(s)
Lodosyn
Intervention Description
30 minutes prior to the PET scan, patients will receive the 200mg oral dose of carbidopa to prevent peripheral [18F]FDOPA metabolism to increase signal-to-noise ratio of the imaging.
Intervention Type
Drug
Intervention Name(s)
Entacapone 400mg oral dose
Other Intervention Name(s)
Comtan
Intervention Description
30 minutes prior to the PET scan, patients will receive the 400mg oral dose of entacapone to prevent peripheral [18F]FDOPA metabolism to increase signal-to-noise ratio of the imaging.
Primary Outcome Measure Information:
Title
Differences in FDOPA uptake across patient populations
Description
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.
Time Frame
95 minutes post-PET after start of PET imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with a diagnosis if pure autonomic failure Patients with autonomic failure and possible PD, MSA, or DLB Healthy adults aged 18 and above 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel O Claassen, MD, MS
Phone
615-936-1007
Email
daniel.claassen@vumc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlyn Hay, MS
Email
kaitlyn.r.hay@vumc.org
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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