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

NCT02012595 | Completed DMC

• 2 other identifiers: 2013-012013-003775-35
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Distribution volume of [11C]donepezil in internal organs

  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.

  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.

Study Arms (2)

Parkinson's patients

Participants with Parkinson's Disease

Other: [11C]donepezil PET

Healthy Controls

Healthy participants

Other: [11C]donepezil PET

Interventions

[11C]donepezil PET OTHER

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

Healthy Controls; Parkinson's patients

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 40-80 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• Per Borghammer: lead
• Lundbeck Foundation: collaborator
• Jascha Fonden: collaborator
• Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark: collaborator

Study Sites (1)

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

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Per Borghammer, MD, PhD,DMSc

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, ph.d.,DMSci

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 16, 2013
• Study Start: October 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 2, 2015

Record last verified: 2015-05

Locations

DK (1)