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| Name | Class |
|---|---|
| Lundbeck Foundation | OTHER |
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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [11C]donepezil PET | Other | Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution Volume (DV) of [11C]Donepezil - BASELINE | 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. | 1 day (One timepoint) |
| Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE | 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. | 1 day (one timepoint) |
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Inclusion Criteria:
Exclusion Criteria:
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7 healthy male volunteers is included in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Per Borghammer, MD,PhD | Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25324520 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | [11C]Donepezil | [11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system [11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil 7 healthy control subjects were scanned in this preliminary pilot study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
7 healthy control subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | [11C]Donepezil PET | [11C]donepezil is a radiopharmaceutical used with Positron Emission Tomography (PET) imaging. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system [11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil 7 healthy control subjects were recruited to this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Distribution Volume (DV) of [11C]Donepezil - BASELINE | 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. | In 6 subjects we analysed Volumes of distribution (Vd) and SUV values in internal organs (parotid, submandibular, spleen, stomach, heart, intestine, pancreas). NOTE: In subject number 7 we examined radioactive dose in 23 target organs (dose: microSv/MBq) and calculated the combined effective dose. The Vd and SUV values listed are from 6 subjects. | Posted | Mean | Standard Deviation | mL | 1 day (One timepoint) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | [11C]Donepezil | [11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system [11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil 7 healthy controls were PET scanned in this preliminary study. No adverse events were detected. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Per Borghammer | Department of Nuclear Medicine & PET Center, Aarhus University Hospital | +0045 23818581 | perborgh@rm.dk |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
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|
| Primary | Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE | 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. | In 6 subjects the SUV values in internal organs were calculated. | Posted | Mean | Standard Deviation | Unitless ratio | 1 day (one timepoint) |
|
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| 0 |
| 7 |
| 0 |
| 7 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Title | Measurements |
|---|---|
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| SUV - Stomach |
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| SUV - Heart |
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| SUV - Intestine |
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| SUV - Pancreas |
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