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Completed

NCT Number: NCT03554551

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

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.

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Key information

Conditions

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

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aarhus University Hospital

Aarhus, Region Midt, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Density of vesicular acetylcholine transporter

    Time frame: Day 1

    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

Secondary outcomes

  1. Correlation to measurements of gastrointestinal denervation

    Time frame: Day 1

    Density of vesicular acetylcholine transporter will be correlated to symptoms of gastrointestinal autonomic denervation (constipation, gastroparesis).

  2. Correlation to measurements of dysautonomia

    Time frame: Day 1

    Density of vesicular acetylcholine transporter will be correlated to measurements of dysautonomia (orthostatic hypotension, colon transit time)

  3. Correlation to measurements of neuropsychological tests

    Time frame: Day 1

    Cerebral density of vesicular acetylcholine transporter is correlated with neuropsychological test scores.

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jun 13, 2018
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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