Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System

NCT ID: NCT01877538

Last Updated: 2016-03-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-07-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Parkinson's Disease

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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[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.

[11C]donepezil PET

Intervention Type OTHER

Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand \[11C\]donepezil

Interventions

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[11C]donepezil PET

Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand \[11C\]donepezil

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Lundbeck Foundation

OTHER

Sponsor Role collaborator

Per Borghammer

OTHER

Sponsor Role lead

Responsible Party

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Per Borghammer

MD, PhD, DMSci

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Per Borghammer, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark

Locations

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Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 25324520 (View on PubMed)

Other Identifiers

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01-01

Identifier Type: -

Identifier Source: org_study_id

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