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

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ClinicalTrials.gov Identifier: NCT01877538
Recruitment Status : Completed
First Posted : June 13, 2013
Results First Posted : March 23, 2016
Last Update Posted : March 23, 2016
Sponsor:
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
Per Borghammer, Aarhus University Hospital

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


Condition or disease Intervention/treatment
Parkinson's Disease Other: [11C]donepezil PET

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.


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Study Type : Observational
Actual Enrollment : 7 participants
Time Perspective: Cross-Sectional
Official Title: "[11C]Donepezil PET for Imaging the Parasympathetic Nervous System in Healthy Adults"
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
[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.
Other: [11C]donepezil PET
Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil




Primary Outcome Measures :
  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.




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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
7 healthy male volunteers is included in this study.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01877538


Locations
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Denmark
Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Per Borghammer
Lundbeck Foundation
Investigators
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Principal Investigator: Per Borghammer, MD,PhD Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark

Publications of Results:
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Responsible Party: Per Borghammer, MD, PhD, DMSci, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01877538     History of Changes
Other Study ID Numbers: 01-01
First Posted: June 13, 2013    Key Record Dates
Results First Posted: March 23, 2016
Last Update Posted: March 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Donepezil
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents