NCT03554551|CompletedDMC
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Sponsor study identifier
observational
30
1 country
1
Study Start
August 8, 2018
Actual (reported)Primary Completion
August 11, 2022
Actual (reported)Study Completion
August 11, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 11, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 31, 2018
Actual (reported)June 13, 2018
Actual (reported)August 8, 2018
Actual (reported)August 11, 2022
Actual (reported)August 11, 2022
Actual (reported)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
Correlation to measurements of gastrointestinal denervation
Day 1
Correlation to measurements of dysautonomia
Day 1
Correlation to measurements of neuropsychological tests
Day 1
Disease duration \> 4 years, Hoehn \& Yahr stage 2-3, 50-85 years old
50-85 years
Parkinson patients are moderate stage disease. Healthy subjects have to meet the criteria below.
Aarhus University Hospital
Aarhus, Region Midt, 8000, Denmark
Horsager J, Okkels N, Van Den Berge N, Jacobsen J, Schact A, Munk OL, Vang K, Bender D, Brooks DJ, Borghammer P. In vivo vesicular acetylcholine transporter density in human peripheral organs: an [18F]FEOBV PET/CT study. EJNMMI Res. 2022 Apr 1;12(1):17. doi: 10.1186/s13550-022-00889-9.
30 participants (actual enrollment reported by the registry).
First Submitted
May 31, 2018
First Posted
June 13, 2018
Study Start
August 8, 2018
Actual (reported)Synaptic Density and Progression of Parkinson's Disease.
Contact the study team to confirm eligibility.
Primary Completion
August 11, 2022
Actual (reported)Study Completion
August 11, 2022
Actual (reported)Last Updated
January 31, 2023
Record last verified: 2023-01
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Source: ClinicalTrials.gov.
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