Parkinson's DiseaseNCT01877538
Study to Investigate the Ability of [11C]Donepezil PET to Image the Parasympathetic Nervous System
An observational study of Parkinson's Disease, run by Per Borghammer at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- [11C]donepezil PET
- How many people
- 7 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Jul 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 7 healthy male volunteers is included in this study.
Who may be able to join
- male
- 45-75 years
Who cannot join
- dementia,
- psychiatric diseases,
- serious medical illness including any type of previous cancer, any drug with known interaction with the autonomic nervous system
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dep. of Nuclear Medicine and PET centre, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: "[11C]Donepezil PET for Imaging the Parasympathetic Nervous System in Healthy Adults"
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
Read the detailed description
Please see the published paper wherein all details are listed:
In vivo imaging of human acetylcholinesterase density in peripheral organs using 11C-donepezil: dosimetry, biodistribution, and kinetic analyses.
Gjerløff T, Jakobsen S, Nahimi A, Munk OL, Bender D, Alstrup AK, Vase KH, Hansen SB, Brooks DJ, Borghammer P. J Nucl Med. 2014 Nov;55(11):1818-24.
- Conditions
- Parkinson's Disease
- Being tested
- [11C]donepezil PET
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]donepezil PETOther
Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Other: [11C]donepezil PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day (one timepoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Borghammer
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation
- Responsible party
- Sponsor-investigator, Per Borghammer, Aarhus University Hospital
- Investigators
- Per Borghammer, MD,PhD, Principal investigator, Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877538
- Sponsor's protocol ID
- 01-01
- Status last verified
- Feb 2016
- First submitted
- 11 Jun 2013
- Last updated
- 23 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25324520
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "[11C]Donepezil PET for Imaging the Parasympathetic Nervous System in Healthy Adults"
- ClinicalTrials.gov ID
- NCT01877538
- Acronym / sponsor ID
- 01-01
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Per BorghammerUniversity, hospital or other
- Collaborators
- Lundbeck Foundation
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Jun 2013 (estimated)
- Results
- Posted 23 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Please see the published paper wherein all details are listed:
In vivo imaging of human acetylcholinesterase density in peripheral organs using 11C-donepezil: dosimetry, biodistribution, and kinetic analyses.
Gjerløff T, Jakobsen S, Nahimi A, Munk OL, Bender D, Alstrup AK, Vase KH, Hansen SB, Brooks DJ, Borghammer P. J Nucl Med. 2014 Nov;55(11):1818-24.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [11C]donepezil PET | – | Other: [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. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 7 healthy male volunteers is included in this study.
Key inclusion criteria (2 listed)
- male
- 45-75 years
Key exclusion criteria (3 listed)
- dementia,
- psychiatric diseases,
- serious medical illness including any type of previous cancer, any drug with known interaction with the autonomic nervous system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]donepezil PETPositron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil | Other | [11C]donepezil PET |
Primary outcome
Distribution Volume (DV) of [11C]Donepezil - BASELINE
Time frame: 1 day (One timepoint)
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.
Standard Uptake Value (SUV) of [11C]Donepezil - BASELINE
Time frame: 1 day (one timepoint)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25324520Gjerloff 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Borghammer, MD,PhD principal investigator
Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Per Borghammer at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution Volume (DV) of [11C]Donepezil - BASELINE (time frame: 1 day (One timepoint)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01877538, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2016.