Trial Outcomes & Findings for Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System (NCT NCT01877538)
NCT ID: NCT01877538
Last Updated: 2016-03-23
Results Overview
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.
COMPLETED
7 participants
1 day (One timepoint)
2016-03-23
Participant Flow
Participant milestones
| Measure |
[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.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System
Baseline characteristics by cohort
| Measure |
[11C]Donepezil PET
n=7 Participants
\[11C\]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.
|
|---|---|
|
Age, Continuous
|
64.7 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 day (One timepoint)Population: 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.
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.
Outcome measures
| Measure |
[11C]Donepezil PET
n=6 Participants
\[11C\]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
|
|---|---|
|
Distribution Volume (DV) of [11C]Donepezil - BASELINE
Vd - Parotid
|
18.0 mL
Standard Deviation 3.3
|
|
Distribution Volume (DV) of [11C]Donepezil - BASELINE
Vd - Submandibular
|
22.1 mL
Standard Deviation 5.0
|
|
Distribution Volume (DV) of [11C]Donepezil - BASELINE
Vd - Spleen
|
21.4 mL
Standard Deviation 7.6
|
|
Distribution Volume (DV) of [11C]Donepezil - BASELINE
Vd - Stomach
|
26.6 mL
Standard Deviation 11.5
|
|
Distribution Volume (DV) of [11C]Donepezil - BASELINE
Vd - Heart
|
46.8 mL
Standard Deviation 7.8
|
|
Distribution Volume (DV) of [11C]Donepezil - BASELINE
Vd - Intestine
|
103.9 mL
Standard Deviation 19.5
|
|
Distribution Volume (DV) of [11C]Donepezil - BASELINE
Vd - Pancreas
|
189.8 mL
Standard Deviation 103.9
|
PRIMARY outcome
Timeframe: 1 day (one timepoint)Population: In 6 subjects the SUV values in internal organs were calculated.
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.
Outcome measures
| Measure |
[11C]Donepezil PET
n=6 Participants
\[11C\]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
|
|---|---|
|
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
SUV - Parotid
|
2.3 Unitless ratio
Standard Deviation 0.5
|
|
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
SUV - Submandibular
|
3.9 Unitless ratio
Standard Deviation 1.1
|
|
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
SUV - Spleen
|
3.7 Unitless ratio
Standard Deviation 1.4
|
|
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
SUV - Stomach
|
4.8 Unitless ratio
Standard Deviation 1.2
|
|
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
SUV - Heart
|
7.4 Unitless ratio
Standard Deviation 0.8
|
|
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
SUV - Intestine
|
11.7 Unitless ratio
Standard Deviation 2.4
|
|
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
SUV - Pancreas
|
19.1 Unitless ratio
Standard Deviation 4.2
|
Adverse Events
[11C]Donepezil
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Per Borghammer
Department of Nuclear Medicine & PET Center, Aarhus University Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place