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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2025
  • participants needed
    40
  • sponsor
    Daniel Claassen
Updated on 1 May 2022
dopamine
positron emission tomography
dementia
atrophy
parkinson's disease
demented
carbidopa
multiple system atrophy
entacapone
lewy body dementia
dopa
synucleinopathy
nervous system disorder
pure autonomic failure
alpha-synuclein
Accepts healthy volunteers

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.

Details
Condition Autonomic Failure, Pure Autonomic Failure, Parkinson Disease, Multiple System Atrophy, Dementia With Lewy Bodies
Treatment [18F]FDOPA, Carbidopa 200mg oral dose, Entacapone 400mg oral dose
Clinical Study IdentifierNCT04246437
SponsorDaniel Claassen
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note