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

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

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Parkinson's patients with moderate symptoms (diagnosis > 4 years earlier, bilateral disease). Will be recruited through department of neurology Aarhus University Hospital, Denmark.

Healthy controls recruited through local media.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's patients; Participants with Parkinson's Disease	Other: [11C]donepezil PET; Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil
Healthy Controls; Healthy participants	Other: [11C]donepezil PET; Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Per Borghammer
• Collaborators: Lundbeck Foundation; Jascha Fonden; Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
• Investigators: Principal Investigator: Per Borghammer, MD, PhD,DMSc, Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): January 1, 2015

Study Registration Dates

• First Submitted: November 26, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (ESTIMATE): December 16, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 31, 2015
• Last Verified: May 1, 2015

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: 2013-01 (Other Identifier: AP HM); 2013-003775-35 (EUDRACT_NUMBER)