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

NCT ID: NCT03554551

Last Updated: 2023-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-08-08

Study Completion Date

2022-08-11

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Parkinsons disease

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

No interventions assigned to this group

Healthy controls

50-85 years

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jacob Horsager

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus, Region Midt, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 35362761 (View on PubMed)

Other Identifiers

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FEO-PD

Identifier Type: -

Identifier Source: org_study_id

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