Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System

NCT01877538 | Completed Results DMC

• 1 other identifier: 01-01
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

AIM: To validate the tracer \[11C\]donepezil for use in the parasympathetic nervous system. MATERIALS AND METHODS: The Investigators will include 7 healthy males aged 45-75 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. PET/CT scans with \[11C\]donepezil are conducted. Six subjects will receive two PET/CT scans - once for the upper abdominal region and once for the head region two evaluate dynamic binding characteristics of the tracer in internal organ. Additionally, one single subject will receive 5 consecutive whole body PET scans to estimate radioactive dosimetry of this tracer. 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 (2)

• Distribution Volume (DV) of [11C]Donepezil - BASELINE

  Logan's graphical analysis is used to calculate Distribution Volumes in Volumes of interest in internal organs (salivary gland, heart, liver, stomach, intestines, kidneys). Arterial blood sampling with radio metabolite correction is performed.

  1 day (One timepoint)

• Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE

  SUV values were calculated in 7 internal organs. SUV is a unitless ratio. We normalised to injected dose and bodyweight. SUV (organ) = activity concentration (organ; kBq/mL) \* bodyweight (mL) / injected dose (kBq) Note: it is a common assumption when calculating SUV values that bodyweight equals volume, and therefore the unit mL is appropriate.

  1 day (one timepoint)

Study Arms (1)

[11C]donepezil PET

\[11C\]donepezil is a radiopharmaceutical. It is evaluated whether the binding of \[11C\]donepezil in various peripheral tissues is in accordance with known distribution of the parasympathetic nervous system.

Other: [11C]donepezil PET

Interventions

[11C]donepezil PET OTHER

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

[11C]donepezil PET

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

7 healthy male volunteers is included in this study.

You may qualify if:

• male
• 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

Sponsors & Collaborators

• Per Borghammer: lead
• Lundbeck Foundation: collaborator

Study Sites (1)

Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (1)

• Gjerloff T, Jakobsen S, Nahimi A, Munk OL, Bender D, Alstrup AK, Vase KH, Hansen SB, Brooks DJ, Borghammer P. In vivo imaging of human acetylcholinesterase density in peripheral organs using 11C-donepezil: dosimetry, biodistribution, and kinetic analyses. J Nucl Med. 2014 Nov;55(11):1818-24. doi: 10.2967/jnumed.114.143859. Epub 2014 Oct 16.

  PMID: 25324520 RESULT

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

Results Point of Contact

• Title: Dr. Per Borghammer
• Organization: Department of Nuclear Medicine & PET Center, Aarhus University Hospital

perborgh@rm.dk

+0045 23818581

Study Officials

• Per Borghammer, MD,PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, DMSci

Study Record Dates

• First Submitted: June 11, 2013
• First Posted: June 13, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 23, 2016
• Results First Posted: March 23, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)