About this trial
In this study, the investigators aim to find a biomarker of Parkinson's disease. This is done using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The findings will provide a deeper understanding of the brain changes in Parkinson's disease. More importantly, this study will help with the discovery and development of new medications aiming to delay progression of PD symptoms.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All subjects must be judged by the investigator able to understand the nature, design, and procedures of the study and must be able to provide a signed and dated informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations.
All subjects must be willing and able to comply with scheduled visits, required study procedures and laboratory tests.
All subjects must be able to travel to the research sites for the study procedures.
For female subjects: They must be either of non-childbearing potential (either surgically sterile or post- menopausal - defined as 12 months of spontaneous amenorrhea), or, if of childbearing potential, subjects must demonstrate to be non-pregnant (as demonstrated by negative urine β-HCG test at screening), non-breastfeeding.
Disqualifiers
Subjects lacking capacity according to investigator judgement.
Subjects with a clinical diagnosis of dementia as determined by the investigator.
Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude safe completion of the lumbar puncture.
Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
Trial population
A cohort of asymptomatic and symptomatic carriers of genetic mutations for familial forms of Parkinson's Disease, and previously collected data from healthy controls.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Positron Emission Tomography (PET) scan using DASB tracer
Other interventionDASB is a highly selective PET radioligand for serotonin transporter and is a reliable tool to investigate serotonin terminals and neurons. The included Magnetic Resonance Imaging (MRI) sequences serve to provide additional information plus complement PET data. To quantify dopaminergic pathology with \[123I\]FP-CIT SPECT,
Treatment groups
Trial outcomes
Primary outcomes
DASB (a marker of Serotonin transporter) used to quantify in vivo pathology of serotonin
To quantify serotonergic pathology with \[11C\]3-amino-4-(2- imethylaminomethylphenylsulfanyl)-benzonitrile (DASB) Positron Emission Tomography (PET)
SPECT to measure brain molecular pathology
To quantify serotonergic pathology with \[11C\]DASB PET and dopaminergic pathology with Single-photon Emission Computed Tomography (SPECT)
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity.
Other outcomes
Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS) to determine if there is a correlation with neuropsychological and behavioural evaluation.
A rating tool used to gauge the course of Parkinson's disease in patients
Montreal Cognitive Assessment (MOCA) to determine if there is a correlation with neuropsychological and behavioural evaluation
A cognitive screening test designed to assist in the detection of mild cognitive impairment. Scored out of 30.
Cambridge Neuropsychological Test Automated Battery (CANTAB) to determine if there is a correlation with neuropsychological and behavioural evaluation
Administered to detect cognitive issues \& brain disorders efficiently.
Symbol Digit Modalities Test (SDMT) to determine if there is a correlation with neuropsychological and behavioural evaluation
To be used in screening for organic cerebral dysfunction sored out of 110
Sponsors and contacts
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