An observational study in Parkinson's Disease, sponsored by Per Borghammer. Completed at 1 site in Denmark. Open to male participants aged 45 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-23.
Sponsored by Per Borghammer · Observational
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 7 is below the median of 96 across 1,057 observational studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Per Borghammer is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
7 healthy male volunteers is included in this study.
Exclusion Criteria:
\[11C\]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
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.
Time frame: 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.
Time frame: 1 day (one timepoint)
| Milestone | [11C]Donepezil |
|---|---|
| Started | 7 |
| Completed | 7 |
| Not completed | 0 |
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.
| mL | [11C]Donepezil PET |
|---|---|
| Vd - Parotid | 18.0 ± 3.3 |
| Vd - Submandibular | 22.1 ± 5.0 |
| Vd - Spleen | 21.4 ± 7.6 |
| Vd - Stomach | 26.6 ± 11.5 |
| Vd - Heart | 46.8 ± 7.8 |
| Vd - Intestine | 103.9 ± 19.5 |
| Vd - Pancreas | 189.8 ± 103.9 |
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.
| Unitless ratio | [11C]Donepezil PET |
|---|---|
| SUV - Parotid | 2.3 ± 0.5 |
| SUV - Submandibular | 3.9 ± 1.1 |
| SUV - Spleen | 3.7 ± 1.4 |
| SUV - Stomach | 4.8 ± 1.2 |
| SUV - Heart | 7.4 ± 0.8 |
| SUV - Intestine | 11.7 ± 2.4 |
| SUV - Pancreas | 19.1 ± 4.2 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| [11C]Donepezil | — | 0/7 (0%) | 0/7 (0%) |
7 healthy control subjects
| Age, Continuous(years) | [11C]Donepezil PET |
|---|---|
| Mean | 64.7 ± 6.3 |
| Sex: Female, Male(Participants) | [11C]Donepezil PET |
|---|---|
| Female | 0 |
| Male | 7 |
Plan to share: No
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