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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Daniel Claassen
Study ID
NCT04246437
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [18F]FDOPA — DRUG
    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.
  • Carbidopa 200mg oral dose — DRUG
    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.
  • Entacapone 400mg oral dose — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 4, 2020
Status verified
Mar 2026
Primary completion
Feb 1, 2027
Completion
Feb 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Differences in FDOPA uptake across patient populations [ Time Frame: 95 minutes post-PET after start of PET imaging ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212-

Find similar trials in Nashville, TN

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Vanderbilt University Medical Center· Nashville, TN

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