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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02012595
Enrollment
24
Registered
2013-12-16
Start date
2013-10-31
Completion date
2015-01-31
Last updated
2015-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease

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

Interventions

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

Sponsors

Lundbeck Foundation
CollaboratorOTHER
Jascha Fonden
CollaboratorOTHER
Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
CollaboratorOTHER
Per Borghammer
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Distribution volume of [11C]donepezil in internal organsThe 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026