[18F]FDOPA Imaging for Parkinson's Disease
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug [18F]FDOPA for Parkinson's Disease?
Research shows that F-18 FDOPA PET imaging is effective in identifying Parkinson's disease by measuring dopaminergic activity, which is crucial for diagnosing and understanding the disease. Additionally, studies indicate that [18F]FDOPA provides reliable imaging results, which can help in assessing the progression of Parkinson's disease.12345
Is [18F]FDOPA safe for use in humans?
How is the drug [18F]FDOPA unique in treating Parkinson's disease?
[18F]FDOPA is unique because it is used as a radiotracer in PET imaging to evaluate presynaptic dopaminergic function in the brain, helping to diagnose Parkinson's disease and differentiate it from other conditions. Unlike typical treatments that aim to manage symptoms, [18F]FDOPA provides detailed insights into the brain's dopamine system, which is crucial for understanding the disease's progression.24789
What is the purpose of this trial?
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 Criteria
This trial is for adults with a diagnosis of pure autonomic failure or those who may have Parkinson's Disease (PD), Multiple System Atrophy (MSA), or Dementia with Lewy Bodies (DLB). Healthy adults can also participate. Excluded are pregnant women, minors, prisoners, individuals with certain bioimplants, mental disabilities preventing informed consent, and those unable to follow the study protocol.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants receive [18F]F-DOPA for PET imaging to measure pre-synaptic dopamine in the brain
Follow-up
Participants are monitored for safety and effectiveness after imaging
Treatment Details
Interventions
- [18F]FDOPA
- Carbidopa
- Entacapone
[18F]FDOPA is already approved in United States, European Union for the following indications:
- Diagnostic imaging for neurodegenerative disorders such as Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies
- Diagnostic imaging for neurodegenerative disorders such as Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daniel Claassen
Lead Sponsor