[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

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Aarhus, 8000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[11C]donepezil PET

Other

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

Primary outcomes

Distribution volume of [11C]donepezil in internal organs

Time frame: 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.

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.

Sponsors and collaborators

Lead sponsor

Per Borghammer

Other

Collaborators

Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
Jascha Fonden
Lundbeck Foundation

Registry information

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Dec 16, 2013
Registry last updated: Jun 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed