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NCT Number: NCT01877538

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

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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

45 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital

Aarhus, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[11C]donepezil PET

Other

Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil

Primary outcomes

  1. Distribution Volume (DV) of [11C]Donepezil - BASELINE

    Time frame: 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.

  2. Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Per Borghammer

Other

Collaborators

  • Lundbeck Foundation

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 13, 2013
Registry last updated
Mar 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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