Parkinson DiseaseNCT04243304
Synaptic Density and Progression of Parkinson's Disease.
A study testing 11C-UCB-J PET-CT and 18F-PE2I PET-MR in people with Parkinson Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD. DESIGN: We will include 30 PD patients and 20 healthy controls. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- 11C-UCB-J PET-CT and 18F-PE2I PET-MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Oct 2018to 28 Feb 2022
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PD diagnosis based on MDS clinical diagnostic criteria for Parkinson's disease
- Less than 5 years disease duration since motor symptom onset according to the patient
- Hoehn-Yahr stage 1 or 2 in medication ON state
- Capacity to understand the informed consent form
Who cannot join
- Neuropsychiatric diseases other than PD
- Major internal medical diseases
- Relevant abnormalities on MR brain
- History of alcohol or drug abuse
- Contraindications for MR
- Pregnancy
- Previous participation in other research studies involving ionizing radiation with > 1 mSv over past 12 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson's Disease.
AIM: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD.
DESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and after 2 years.
- Conditions
- Parkinson Disease
- Being tested
- 11C-UCB-J PET-CT, 18F-PE2I PET-MR
- Keywords
- Parkinson Disease, PET, UCB-J, PE2I
- 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-UCB-J PET-CTOther
Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
18F-PE2I PET-MROther
Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.
| Study group | Role | What they receive |
|---|---|---|
| PD patients | Experimental | At baseline and 2-year follow-up Receives: Other: 11C-UCB-J PET-CT; Other: 18F-PE2I PET-MR |
| Healthy controls | Active comparator | At baseline and 2-year follow-up Receives: Other: 11C-UCB-J PET-CT; Other: 18F-PE2I PET-MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline differences in synaptic density.
Baseline differences (%) in synaptic density between patients and controls.
Measured: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Correlations between clinical scores and synaptic density.
Correlations between clinical scores and synaptic density in the patient group.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of synaptic density.
Differences (%) in the rate of decline of synaptic density between patients and controls.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of synaptic density.
Correlations between progression of the clinical scores and decline of synaptic density in the patient group.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Secondary outcomes (4)
Baseline differences in DAT levels.
Baseline differences (%) in DAT levels between patients and controls.
Measured: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Correlations between clinical scores and DAT levels.
Correlations between clinical scores and DAT levels in the patient group.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of global and DAT levels.
Differences (%) in the rate of decline of global and DAT levels between patients and controls.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of DAT levels.
Correlations between progression of the clinical scores and decline of DAT levels in the patient group.
Measured: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Oct 2018
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Longitudinal study design (2 years follow up) where results of SV2A PET/CT, PE2I PET/MR and clinical rating scales are compared between PD patients and healthy controls.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wim Vandenberghe, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243304
- Sponsor's protocol ID
- s61477
- Status last verified
- May 2022
- First submitted
- 10 Jan 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Needs to be decided.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Measurement of Synaptic Density to Monitor Progression of Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT04243304
- Acronym / sponsor ID
- s61477
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, PET, UCB-J, PE2I
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 28 Jan 2020 (actual)
- 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: To assess synaptic density and to investigate the potential relationship of regional synaptic loss with motor and non-motor symptoms and with disease progression in the human brain in vivo in patients with PD.
DESIGN: We will include 30 PD patients and 20 healthy controls. All subjects will undergo a clinical examination, with comprehensive assessment of motor and non-motor symptoms, and imaging evaluation consisting of 11C-UCB-J PET-CT and 18F-FE-PE2I PET-MR at baseline and after 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Longitudinal study design (2 years follow up) where results of SV2A PET/CT, PE2I PET/MR and clinical rating scales are compared between PD patients and healthy controls.
| Arm | Type | Receives |
|---|---|---|
| PD patients | Experimental | Other: 11C-UCB-J PET-CT, Other: 18F-PE2I PET-MRAt baseline and 2-year follow-up |
| Healthy controls | Active comparator | Other: 11C-UCB-J PET-CT, Other: 18F-PE2I PET-MRAt baseline and 2-year follow-up |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- PD diagnosis based on MDS clinical diagnostic criteria for Parkinson's disease
- Less than 5 years disease duration since motor symptom onset according to the patient
- Hoehn-Yahr stage 1 or 2 in medication ON state
- Capacity to understand the informed consent form
Key exclusion criteria (7 listed)
- Neuropsychiatric diseases other than PD
- Major internal medical diseases
- Relevant abnormalities on MR brain
- History of alcohol or drug abuse
- Contraindications for MR
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-UCB-J PET-CTPositron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J. | Other | Healthy controls, PD patients |
| 18F-PE2I PET-MRPositron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously. | Other | Healthy controls, PD patients |
Primary outcome
Baseline differences in synaptic density.
Time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Baseline differences (%) in synaptic density between patients and controls.
Correlations between clinical scores and synaptic density.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between clinical scores and synaptic density in the patient group.
Differences in the rate of decline of synaptic density.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Differences (%) in the rate of decline of synaptic density between patients and controls.
Correlations between progression of the clinical scores and decline of synaptic density.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of synaptic density in the patient group.
4 secondary outcomes
Baseline differences in DAT levels.
Time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.
Correlations between clinical scores and DAT levels.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Differences in the rate of decline of global and DAT levels.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
Correlations between progression of the clinical scores and decline of DAT levels.
Time frame: Data analysis wel be done when all subjects have undergone the 2-year follow-up evaluation.
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 19 May 2022.
- Individual participant dataSharing planned: Yes. Needs to be decided.
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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.
Wim Vandenberghe, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 11C-UCB-J PET-CT and 18F-PE2I PET-MR in people with Parkinson Disease, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 4 inclusion and 7 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 19 May 2022. 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 Belgium. 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?
Baseline differences in synaptic density. (time frame: Data analysis wel be done when all subjects have undergone the baseline evaluation.). The study lists 4 primary outcomes in all. 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 19 May 2022.