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

Completed

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

dementia,
psychiatric diseases,
serious medical illness including any type of previous cancer, any drug with known interaction with the autonomic nervous system

Arm && Interventions

Group	Intervention	Description
[11C]donepezil PET	[11C]donepezil PET	\[11C\]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.

Primary Outcome Measures

Name	Time	Method
Distribution Volume (DV) of [11C]Donepezil - BASELINE	1 day (One timepoint)	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.
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE	1 day (one timepoint)	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.