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

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ClinicalTrials.gov Identifier: NCT02012595
Recruitment Status : Completed
First Posted : December 16, 2013
Last Update Posted : June 2, 2015
Sponsor:
Collaborators:
Lundbeck Foundation
Jascha Fonden
Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
Information provided by (Responsible Party):
Per Borghammer, Aarhus University Hospital

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


Condition or disease Intervention/treatment
Parkinson's Disease Other: [11C]donepezil PET

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: [11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease
Study Start Date : October 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02012595


Locations
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Denmark
Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
Per Borghammer
Lundbeck Foundation
Jascha Fonden
Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
Investigators
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Principal Investigator: Per Borghammer, MD, PhD,DMSc Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark

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Responsible Party: Per Borghammer, MD, ph.d.,DMSci, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT02012595     History of Changes
Other Study ID Numbers: 2013-01
2013-003775-35 ( EudraCT Number )
First Posted: December 16, 2013    Key Record Dates
Last Update Posted: June 2, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Donepezil
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents