[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease

Study Overview
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Brief Summary
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AIM: Investigate wether there are differences in the parasympathetic nervous system in Parkinsons patients compared to controls. MATERIALS AND METHODS: We use the tracer [11C]donepezil to image the parasympathetic nervous system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged 40-80 in our study. The participants will receive a careful medical examination, including a neurological examination, as part of the inclusion process. The subjects also have an MRI scan of the brain. Then PET/CT scans with [11C]donepezil are conducted - once for the upper abdominal region and once for the head region. For evaluating the function of the parasympathetic nervous system gastric emptying time, heart rate variability and salivary flow will be measured. These measureless will be correlated to the PET findings. PERSPECTIVES: The study will potentially result in the development of a PET ligand for imaging the parasympathetic nervous system. This will have applications for research in Parkinson's disease, diabetes, heart disease and other disorders, in which the autonomic nervous system is involved

Official Title
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[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: [11C]donepezil PET


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-80 years Exclusion Criteria: dementia, psychiatric diseases, serious medical illness including any type of previous cancer any drug with known interaction with the autonomic nervous system metal in the body (because of MRI scan) pregnancy or breast feeding (because of radiation due to PET/CT) known diseases of the salivary glands, stomach, intestines. Prior major surgery to salivary glands, esophagus, stomach.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's patients<br>Participants with Parkinson's Disease | Other: [11C]donepezil PET<br>* Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil<br>|
| Healthy Controls<br>Healthy participants | Other: [11C]donepezil PET<br>* Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution volume of [11C]donepezil in internal organs | Our primary endpoint is the distribution volume of [11C]donepezil in internal organs (including salivary glands, heart, stomach and intestines) in Parkinson's patients compared to controls. | The distribution volume of [11C]donepezil is measured at Day 1 by PET/CT scanning each participant. The data analysis is done when all participants have completed the study. |