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

Study Overview
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Brief Summary
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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.

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

Conditions
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Parkinson Disease

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Parkinsons disease<br>Disease duration > 4 years, Hoehn & Yahr stage 2-3, 50-85 years old | |
| Healthy controls<br>50-85 years | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Density of vesicular acetylcholine transporter | Average density will be determined in each group for intestine, pancreas, suprarenal gland, heart and relevant areas of the brain. Group differences will be calculated | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation to measurements of gastrointestinal denervation | Density of vesicular acetylcholine transporter will be correlated to symptoms of gastrointestinal autonomic denervation (constipation, gastroparesis). | Day 1 | 
| Correlation to measurements of dysautonomia | Density of vesicular acetylcholine transporter will be correlated to measurements of dysautonomia (orthostatic hypotension, colon transit time) | Day 1 | 
| Correlation to measurements of neuropsychological tests | Cerebral density of vesicular acetylcholine transporter is correlated with neuropsychological test scores. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parasympathetic