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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

Tracking Information
First Submitted Date June 11, 2013
First Posted Date June 13, 2013
Results First Submitted Date May 31, 2015
Results First Posted Date March 23, 2016
Last Update Posted Date March 23, 2016
Study Start Date May 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2016)
  • 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.
Original Primary Outcome Measures
 (submitted: June 12, 2013)
Distribution Volume (DV) of [11C]donepezil in internal organs [ 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.
Change History Complete list of historical versions of study NCT01877538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System
Official Title "[11C]Donepezil PET for Imaging the Parasympathetic Nervous System in Healthy Adults"
Brief Summary

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

Detailed Description

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
Study Design Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 7 healthy male volunteers is included in this study.
Condition Parkinson's Disease
Intervention Other: [11C]donepezil PET
Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil
Study Groups/Cohorts [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.
Intervention: Other: [11C]donepezil PET
Publications * Gjerløff 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 30, 2013)
7
Original Estimated Enrollment
 (submitted: June 12, 2013)
6
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Male
Ages 45 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01877538
Other Study ID Numbers 01-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Per Borghammer, Aarhus University Hospital
Study Sponsor Per Borghammer
Collaborators Lundbeck Foundation
Investigators
Principal Investigator: Per Borghammer, MD,PhD Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark
PRS Account University of Aarhus
Verification Date February 2016