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

NCT ID: NCT02012595

Last Updated: 2015-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Parkinson's patients

Participants with Parkinson's Disease

[11C]donepezil PET

Intervention Type OTHER

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

Healthy Controls

Healthy participants

[11C]donepezil PET

Intervention Type OTHER

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

Interventions

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[11C]donepezil PET

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lundbeck Foundation

OTHER

Sponsor Role collaborator

Jascha Fonden

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

Per Borghammer

OTHER

Sponsor Role lead

Responsible Party

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Per Borghammer

MD, ph.d.,DMSci

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Per Borghammer, MD, PhD,DMSc

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2013-003775-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013-01

Identifier Type: -

Identifier Source: org_study_id

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