Clinical trial NCT01877538: Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System
Official title: "[11C]Donepezil PET for Imaging the Parasympathetic Nervous System in Healthy Adults"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2013-06-13
Enrollment: 7
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 7 healthy male volunteers is included in this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distribution Volume (DV) of [11C]Donepezil - BASELINE
timeFrame: 1 day (One timepoint)
measure: Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
timeFrame: 1 day (one timepoint)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital
Study officials:
affiliation: Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark
name: Per Borghammer, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gjerloff T, Jakobsen S, Nahimi A, Munk OL, Bender D, Alstrup AK, Vase KH, Hansen SB, Brooks DJ, Borghammer P. In vivo imaging of human acetylcholinesterase density in peripheral organs using 11C-donepezil: dosimetry, biodistribution, and kinetic analyses. J Nucl Med. 2014 Nov;55(11):1818-24. doi: 10.2967/jnumed.114.143859. Epub 2014 Oct 16.