Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System
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| ClinicalTrials.gov Identifier: NCT01877538 |
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Recruitment Status :
Completed
First Posted : June 13, 2013
Results First Posted : March 23, 2016
Last Update Posted : March 23, 2016
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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
| Condition or disease | Intervention/treatment |
|---|---|
| Parkinson's Disease | Other: [11C]donepezil PET |
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.
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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[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.
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Other: [11C]donepezil PET
Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil |
- 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.
- 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 |
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
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
| Denmark | |
| Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital | |
| Aarhus, Denmark, 8000 | |
| Principal Investigator: | Per Borghammer, MD,PhD | Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark |
Publications of Results:
| 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 |
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents |