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

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ClinicalTrials.gov Identifier: NCT03554551
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Jacob Horsager, Aarhus University Hospital

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.

Condition or disease
Parkinson Disease

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Imaging the Vesicular Acetylcholine Transporter Using 18Fluoro-fluoroethoxybenzovesamicol (18F-FEOBV) Positron Emission Tomography(PET) in Parkinsons Disease
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with Parkinsons disease
Disease duration > 4 years, Hoehn & Yahr stage 2-3, 50-85 years old
Healthy controls
50-85 years



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parkinson patients are moderate stage disease. Healthy subjects have to meet the criteria below.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554551


Contacts
Contact: Jacob Horsager, M.D. +4526819204 jacobnls@rm.dk
Contact: Per Borghammer, MD, DMSc, PhD +4528261039 perborgh@rm.dk

Sponsors and Collaborators
Aarhus University Hospital

Responsible Party: Jacob Horsager, Principal investigator, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT03554551     History of Changes
Other Study ID Numbers: FEO-PD
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jacob Horsager, Aarhus University Hospital:
Parasympathetic

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Acetylcholine
Vasodilator Agents
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs