Clinical trial NCT02012595: [11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease
Official title: [11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
name: Jascha Fonden
name: Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
First posted: 2013-12-16
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: Distribution volume of [11C]donepezil in internal organs
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital
Study officials:
affiliation: Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark
name: Per Borghammer, MD, PhD,DMSc
role: PRINCIPAL_INVESTIGATOR
References: