Molecular and Functional Imaging in SNCA, Parkin and PINK1
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ClinicalTrials.gov Identifier: NCT04084509 |
Recruitment Status :
Withdrawn
(Change of circumstances for CI/PI.)
First Posted : September 10, 2019
Last Update Posted : April 6, 2020
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Tracking Information | |||||
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First Submitted Date | August 8, 2019 | ||||
First Posted Date | September 10, 2019 | ||||
Last Update Posted Date | April 6, 2020 | ||||
Estimated Study Start Date | October 1, 2019 | ||||
Estimated Primary Completion Date | September 30, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Primary Outcomes [ Time Frame: Up to 21 days ] To quantify serotonergic and dopaminergic pathology in carriers of genetic mutations for familial forms of Parkinsonism, idiopathic PD patients and healthy controls.
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Molecular and Functional Imaging in SNCA, Parkin and PINK1 | ||||
Official Title | Molecular and Functional Imaging of Parkinson's Pathology in SNCA, Parkin and PINK1 Mutation Carriers | ||||
Brief Summary | Parkinson's Disease (PD) is a progressive neurodegenerative disease characterized clinically by bradykinesia, resting tremor, rigidity, and postural instability. The hallmark pathophysiological alteration is a loss of dopaminergic transmission across the nigrostriatal pathway. According to Braak's neuropathological staging of disease, the pathological process in PD occurs in a gradual ascending fashion, starting from the olfactory bulb and progressing to the brainstem, with preferential involvement of the raphe nuclei, which contain serotonergic nuclei, and the noradrenergic locus coeruleus, before involving the substantia nigra and thereafter the whole brain. Little is known about the mechanisms underlying neuronal degeneration in PD and currently, no treatment is available to halt disease progression in PD. The pathophysiological characterisation of phenomena occurring in the time window between the pathological start of the disease and the onset of motor symptoms is crucial to develop potential neuroprotective agents. Several genes causing, the so-called monogenic parkinsonism, have been discovered providing important insights on the pathogenesis of PD. The objective of the study is to characterize the molecular phenomena underlying genetic forms of parkinsonism and, therefore, providing further insights about the possible mechanisms taking place in PD and help identify targets for disease-modifying therapeutics, by using PET imaging with [11C]DASB (a marker of Serotonin transporter), SPECT imaging using [123I]FP-CIT (a marker of the presynaptic Dopamine transporter), and multi-modal MRI imaging, clinical markers (motor and non-motor symptoms and neuropsychological battery), blood and CSF biomarkers. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Healthy Controls Idiopathic Parkinson's Disease Symptomatic Genetic Carriers (SNCA, Parkin or PINK1) Asymptomatic Genetic Carriers (SNCA, Parkin or PINK1) | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Withdrawn | ||||
Actual Enrollment |
0 | ||||
Original Estimated Enrollment |
44 | ||||
Estimated Study Completion Date | September 30, 2022 | ||||
Estimated Primary Completion Date | September 30, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria (for all subjects):
Oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation: Intrauterine device (IUD) Intrauterine hormone-releasing system (IUS) Bilateral tubal occlusion Vasectomised partner Sexual abstinence
Exclusion Criteria (for all subjects):
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Sex/Gender |
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Ages | 25 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Not Provided | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04084509 | ||||
Other Study ID Numbers | 263369 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | King's College London | ||||
Study Sponsor | King's College London | ||||
Collaborators |
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Investigators |
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PRS Account | King's College London | ||||
Verification Date | August 2019 |