Parkinson's DiseaseNCT02012595
[11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease
An observational study of Parkinson's Disease, run by Per Borghammer at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- [11C]donepezil PET
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2013to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 40-80 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
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital
Aarhus, 8000
About this study
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
- 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
Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's patients | Participants with Parkinson's Disease Receives: Other: [11C]donepezil PET | |
| Healthy Controls | Healthy participants Receives: Other: [11C]donepezil PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Borghammer
- Sponsor type
- University, hospital or other
- Collaborators
- Lundbeck Foundation, Jascha Fonden, Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
- Responsible party
- Sponsor-investigator, Per Borghammer, Aarhus University Hospital
- Investigators
- Per Borghammer, MD, PhD,DMSc, Principal investigator, Dept. of Nuclear Medicine & PET Center, Aarhus University Hospital, Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02012595
- Sponsor's protocol ID
- 2013-01
- Other IDs
- 2013-003775-35
- Status last verified
- May 2015
- First submitted
- 26 Nov 2013
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [11C]Donepezil PET For Imaging The Autonomous Nervous System In Parkinsons Disease
- ClinicalTrials.gov ID
- NCT02012595
- Acronym / sponsor ID
- 2013-01
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Per BorghammerUniversity, hospital or other
- Collaborators
- Lundbeck Foundation, Jascha Fonden, Fonden af 2. Juli 1984 til bekæmpelse af Parkinsons Sygdom, Denmark
- Study start
- Oct 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 16 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's patients | – | Other: [11C]donepezil PETParticipants with Parkinson's Disease |
| Healthy Controls | – | Other: [11C]donepezil PETHealthy participants |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Age 40-80 years
Key exclusion criteria (8 listed)
- 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)
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 PETPositon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil | Other | Healthy Controls, Parkinson's patients |
Primary outcome
Distribution volume of [11C]donepezil in internal organs
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
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,DMSc 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 1 inclusion and 8 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 2 Jun 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of [11C]donepezil in internal organs (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jun 2015.