[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease

Parkinson's Disease Clinical Trial

Official title:

[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012595
• Other study ID #: 2013-01
• Secondary ID: 2013-003775-35
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: May 31, 2015
• Start date: October 2013
• Est. completion date: January 2015

Study information

• Verified date: May 2015
• 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: Investigate wether there are differences in the parasympathetic nervous system in Parkinsons patients compared to controls.

MATERIALS AND METHODS: We use the tracer [11C]donepezil to image the parasympathetic nervous system. The Investigators will include 20 Parkinsons patients and 20 healthy controls aged 40-80 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. Then PET/CT scans with [11C]donepezil are conducted - once for the upper abdominal region and once for the head region. For evaluating the function of the parasympathetic nervous system gastric emptying time, heart rate variability and salivary flow will be measured. These measureless will be correlated to the PET findings.

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: 24
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 40-80 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

• metal in the body (because of MRI scan)

• pregnancy or breast feeding (because of radiation due to PET/CT)

• known diseases of the salivary glands, stomach, intestines.

• Prior major surgery to salivary glands, esophagus, stomach.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• [11C]donepezil PET
Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil

Locations

Country	Name	City	State
Denmark	Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital	Aarhus

Sponsors (4)

Lead Sponsor	Collaborator
Per Borghammer	Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Jascha Fonden, Lundbeck Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution volume of [11C]donepezil in internal organs	Our primary endpoint is the distribution volume of [11C]donepezil in internal organs (including salivary glands, heart, stomach and intestines) in Parkinson's patients compared to controls.	The distribution volume of [11C]donepezil is measured at "Day 1" by PET/CT scanning each participant. The data analysis is done when all participants have completed the study.	No