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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

Study Type Observational
Study Design Time Perspective: Cross-Sectional
Condition Parkinson's Disease
Intervention Other: [11C]donepezil PET
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title [11C]Donepezil
Hide Arm/Group Description

[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.

Period Title: Overall Study
Started 7
Completed 7
Not Completed 0
Arm/Group Title [11C]Donepezil PET
Hide Arm/Group Description

[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.

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
7 healthy control subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
64.7  (6.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
0
   0.0%
Male
7
 100.0%
1.Primary Outcome
Title Distribution Volume (DV) of [11C]Donepezil - BASELINE
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title [11C]Donepezil PET
Hide Arm/Group Description:

[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

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: mL
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)
2.Primary Outcome
Title Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
Hide Description

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)
Hide Outcome Measure Data
Hide Analysis Population Description
In 6 subjects the SUV values in internal organs were calculated.
Arm/Group Title [11C]Donepezil PET
Hide Arm/Group Description:

[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

Overall Number of Participants Analyzed 6
Mean (Standard Deviation)
Unit of Measure: Unitless ratio
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title [11C]Donepezil
Hide Arm/Group Description

[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.

All-Cause Mortality
[11C]Donepezil
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
[11C]Donepezil
Affected / at Risk (%)
Total   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
[11C]Donepezil
Affected / at Risk (%)
Total   0/7 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Per Borghammer
Organization: Department of Nuclear Medicine & PET Center, Aarhus University Hospital
Phone: +0045 23818581
EMail: perborgh@rm.dk
Layout table for additonal information
Responsible Party: Per Borghammer, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT01877538     History of Changes
Other Study ID Numbers: 01-01
First Submitted: June 11, 2013
First Posted: June 13, 2013
Results First Submitted: May 31, 2015
Results First Posted: March 23, 2016
Last Update Posted: March 23, 2016