Longitudinal Investigation of I2BS in PD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25+
SponsorUniversity of Exeter

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Positron Emission Tomography (PET) scan using BU99008 tracer

    Other intervention

    A 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 intervention

    A 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 intervention

    MRI (magnetic resonance imaging) uses magnets alongside radio waves to create pictures of the brain.

  • Lumbar puncture

    Other intervention

    A 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

44 Participants
are divided into 3 treatment groups
Group A: SNCA (Alpha-synuclein gene)4 interventions
Group B: Idiopathic Parkinson's Disease4 interventions
Group C: Healthy Control4 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
12 Months
2

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)

Time frame
12 Months
3

Magnetic Resonance Imaging (MRI)

Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity..

Time frame
12 Months

Secondary outcomes

Other outcomes

1

Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

To determine if there is a correlation with neuropsychological and behavioural evaluation.

Time frame
12 Months
2

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

Time frame
12 Months
3

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.

Time frame
12 Months
4

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

Time frame
12 Months

Sponsors and contacts

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