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

"[11C]Donepezil PET for Imaging the Parasympathetic Nervous System in Healthy Adults"

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: [11C]donepezil PET

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
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

7 healthy male volunteers is included in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
[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.	Other: [11C]donepezil PET; Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 day (one timepoint)

Collaborators and Investigators

• Sponsor: Per Borghammer
• Collaborators: Lundbeck Foundation
• Investigators: Principal Investigator: Per Borghammer, MD,PhD, Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: June 11, 2013
• First Submitted That Met QC Criteria: June 12, 2013
• First Posted (ESTIMATE): June 13, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 23, 2016
• Last Update Submitted That Met QC Criteria: February 22, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: 01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO