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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877538
• Other study ID #: 01-01
• Status: Completed
• Phase: Phase 1
• First received: June 11, 2013
• Last updated: October 30, 2013
• Start date: May 2013
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Observational

Clinical Trial Summary

AIM: To validate the tracer [11C]donepezil for use in the parasympathetic nervous system.

MATERIALS AND METHODS: The Investigators will include 6 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. The PET/CT scans with [11C]donepezil are conducted - once for the upper abdominal region and once for the head region.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 75 Years

Eligibility

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 Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parasympathetic Nervous System
• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
Denmark	Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
University of Aarhus	Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark, Jascha Fonden, Denmark, Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution Volume (DV) of [11C]donepezil in internal organs	Logan's graphical analysis is used to calculate Distribution Volumes in Volumes of interest in internal organs (salivary glands, heart, liver, stomach, intestines, kidneys). Arterial blood sampling with radio metabolite correction is performed.	1 day (One timepoint)	No