Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System

Study Overview
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Brief Summary
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AIM: To validate the tracer [11C]donepezil for use in the parasympathetic nervous system. MATERIALS AND METHODS: The Investigators will include 7 healthy males aged 45-75 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. PET/CT scans with [11C]donepezil are conducted. Six subjects will receive two PET/CT scans - once for the upper abdominal region and once for the head region two evaluate dynamic binding characteristics of the tracer in internal organ. Additionally, one single subject will receive 5 consecutive whole body PET scans to estimate radioactive dosimetry of this tracer. 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

Detailed Description
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Please see the published paper wherein all details are listed: In vivo imaging of human acetylcholinesterase density in peripheral organs using 11C-donepezil: dosimetry, biodistribution, and kinetic analyses. Gjerløff T, Jakobsen S, Nahimi A, Munk OL, Bender D, Alstrup AK, Vase KH, Hansen SB, Brooks DJ, Borghammer P. J Nucl Med. 2014 Nov;55(11):1818-24.

Official Title
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[11C]Donepezil PET for Imaging the Parasympathetic Nervous System in Healthy Adults

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: male 45-75 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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| [11C]donepezil PET<br>[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding of [11C]donepezil in various peripheral tissues is in accordance with known distribution of the parasympathetic nervous system. | Other: [11C]donepezil PET<br>* Positron Emission Tomography (PET) imaging of acetylcholinesterase with 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 (DV) of [11C]Donepezil - BASELINE | Logan's graphical analysis is used to calculate Distribution Volumes in Volumes of interest in internal organs (salivary gland, heart, liver, stomach, intestines, kidneys). Arterial blood sampling with radio metabolite correction is performed. | 1 day (One timepoint) | 
| Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE | SUV values were calculated in 7 internal organs. SUV is a unitless ratio. We normalised to injected dose and bodyweight. SUV (organ) = activity concentration (organ; kBq/mL) * bodyweight (mL) / injected dose (kBq) Note: it is a common assumption when calculating SUV values that bodyweight equals volume, and therefore the unit mL is appropriate. | 1 day (one timepoint) |