RecruitingPhase 1NCT04246437

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

Sponsor

Daniel Claassen

Enrollment

40 participants

Start Date

Feb 4, 2020

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special brain scan called F-DOPA PET imaging to better understand autonomic failure — a condition where the nervous system doesn't properly regulate automatic body functions like blood pressure and heart rate. The scan looks at how the brain's dopamine system is working. **You may be eligible if:** - You have been diagnosed with pure autonomic failure, or autonomic failure alongside a possible Parkinson's disease, multiple system atrophy (MSA), or Lewy body dementia diagnosis - You are a healthy adult aged 18 or older (healthy volunteers also needed for comparison) - A clinical exam has confirmed your diagnosis **You may NOT be eligible if:** - You have a pacemaker, cochlear implant, neurostimulator, or other electronic or metallic implant in your body - You have cerebral aneurysm clips or metal fragments in your body (e.g., from prior work or war wounds) - You are claustrophobic or unable to undergo MRI scanning Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F]FDOPA

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.

DRUGCarbidopa 200mg oral dose

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.

DRUGEntacapone 400mg oral dose

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.

Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

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NCT04246437

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