About this trial
In this study, the researchers aim to find a biomarker of PD. Using imaging scans called Positron Emission tomography (PET), Single Photon Emission Computed Tomography (SPECT), and Magnetic Resonance Imaging (MRI). The PET and SPECT scans use small amounts of radiation and specific compounds called tracers, to study chemical changes in the brain in a way not possible with any other procedure. The MRI uses magnetic fields to generate images of brain structure and function
Eligibility criteria
This trial accepts 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.
Age 25 years or older.
Disqualifiers
Subjects lacking capacity according to investigator's judgment;
Subjects with a clinical diagnosis of dementia as determined by the investigator;
Subjects with current or a recent history of drug or alcohol abuse/dependence;
Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude the arterial cannulation and the safe completion of the lumbar puncture.
Trial population
A cohort of carriers of SNCA genetic mutations for familial forms of Parkinson's Disease, idiopathic Parkinson's Disease patients and previously collected data from healthy controls
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Positron Emission Tomography (PET) scan using BU99008 tracer
Other interventionA positron emission tomography (PET) scan produce detailed 3-dimensional images of the inside of the body by showing radiation from tracers used to highlight specific areas of the brain.
FP-CIT Single-photon Emission Computed Tomography (SPECT) scan
Other interventionA single-photon emission computerized tomography (SPECT) scan allows analysis of brain function by creating 3D Pictures using compounds called tracers.
Magnetic Resonance Imaging (MRI) Scan
Other interventionMRI (magnetic resonance imaging) uses magnets alongside radio waves to create pictures of the brain.
Lumbar puncture
Other interventionA lumbar puncture is where a thin needle is inserted between the bones in your lower spine using local anaesthetic. This allows the collection of Cerebrospinal fluid ( CSF)
Treatment groups
Trial outcomes
Primary outcomes
PET scan with BU99008 to highlight I2BS and and Astroglia cells.
This used to show the role of Astroglia cell activation in Parkinson's disease to understand the role of Astroglia in Parkinson's disease Pathophysiology
Single Photon Emission Computed Tomography (SPECT) to measure brain molecular pathology
To quantify serotonergic pathology with BU99008 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.
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 scored out of 110
Sponsors and contacts
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