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

NCT03554551 | Completed DMC

• 1 other identifier: FEO-PD
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parasympathetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Correlation to measurements of gastrointestinal denervation

  Day 1

• Correlation to measurements of dysautonomia

  Day 1

• Correlation to measurements of neuropsychological tests

  Day 1

Study Arms (2)

Patients with Parkinsons disease

Disease duration \> 4 years, Hoehn \& Yahr stage 2-3, 50-85 years old

Healthy controls

50-85 years

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson patients are moderate stage disease. Healthy subjects have to meet the criteria below.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35362761 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 31, 2018
• First Posted: June 13, 2018
• Study Start: August 8, 2018
• Primary Completion: August 11, 2022
• Study Completion: August 11, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

DK (1)