NCT04246437 · Phase 1 · RECRUITING

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

This trial uses a special PET scan tracer called F-DOPA to measure dopamine production in the brain. It is studying people with autonomic nervous system disorders — including Parkinson's disease, Dementia with Lewy Bodies, and related conditions — to see if brain imaging can predict who will develop a more serious neurological disease. This is a Phase 1 trial, meaning it is focused on early safety and feasibility, not a proven treatment.

Eligibility criteria

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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-03-16

View full record on ClinicalTrials.gov

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