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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03554551
• Other study ID #: FEO-PD
• Status: Completed
• Start date: August 8, 2018
• Est. completion date: August 11, 2022

Study information

• Verified date: January 2023
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 11, 2022
• Est. primary completion date: August 11, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Region Midt

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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