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Imaging the Vesicular Acetylcholine Transporter Using 18F-FEOBV PET in Parkinsons Disease

Imaging the Vesicular Acetylcholine Transporter Using 18Fluoro-fluoroethoxybenzovesamicol (18F-FEOBV) Positron Emission Tomography(PET) in Parkinsons Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03554551
Enrollment
30
Registered
2018-06-13
Start date
2018-08-08
Completion date
2022-08-11
Last updated
2023-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parasympathetic

Brief summary

Patients with Parkinson's disease (PD) often display symptoms, such as constipation, due to denervation of the cholinergic nerves in the gut. It has been hypothesized that PD initiates in the gut years prior to diagnosis. To gain a detailed understanding of the early stages of PD, techniques for quantification of cholinergic nerves are needed. The PET tracer 18F-FEOBV binds specifically to the vesicular acetylcholine transporter, situated in presynaptic cholinergic nerve terminals. The investigators will investigate 18F-FEOBV uptake in the brain and internal organs of 15 patients with moderate-stage PD and compare to 15 healthy controls. Furthermore, findings are correlated to validated clinical tests of the autonomic nervous system. The aim is to validate 18F-FEOBV PET/CT as a clinical imaging modality to diagnose parasympathetic denervation in PD.

Interventions

None listed

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Parkinsons disease, disease duration \> 4 years, Hoehn & Yahr stage 2-3

Exclusion criteria

* Significant neurological diseases (e.g. stroke, tumor) * Significant psychiatric disease * Previous major surgery on thoracic and/or abdominal organs * Significant medical disease (e.g. heart- or liver failure) * Inflammatory bowel disease * Gluten intolerance * Diabetes * Magnetic Resonance (MR) contraindications (metal in body, claustrophobia) * Allergy to CT-contrast fluid * Pacemaker * Any current or previous cancer involving internal organs * Peripheral neuropathy (except Parkinsons disease related)

Design outcomes

Primary

MeasureTime frameDescription
Density of vesicular acetylcholine transporterDay 1Average density will be determined in each group for intestine, pancreas, suprarenal gland, heart and relevant areas of the brain. Group differences will be calculated

Secondary

MeasureTime frameDescription
Correlation to measurements of gastrointestinal denervationDay 1Density of vesicular acetylcholine transporter will be correlated to symptoms of gastrointestinal autonomic denervation (constipation, gastroparesis).
Correlation to measurements of dysautonomiaDay 1Density of vesicular acetylcholine transporter will be correlated to measurements of dysautonomia (orthostatic hypotension, colon transit time)
Correlation to measurements of neuropsychological testsDay 1Cerebral density of vesicular acetylcholine transporter is correlated with neuropsychological test scores.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026