Longitudinal Investigation of I2BS in PD

Recruiting

• Conditions: Parkinson's Disease; Neurodegenerative Diseases; Positron Emission Tomography; Neurodegeneration; Parkinson's; Parkinson Disease
• Interventions: Other: Positron Emission Tomography (PET) scan using BU99008 tracer; Other: FP-CIT Single-photon Emission Computed Tomography (SPECT) scan; Other: Magnetic Resonance Imaging (MRI) Scan; Other: Lumbar puncture

• Registration Number: NCT05516719
• Lead Sponsor: University of Exeter

Brief Summary

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

Detailed Description

Parkinson's disease is a chronic neurological disease that progresses over time and causes a variety of symptoms, such as slowness of movement, stiffness and shaking. The purpose of this study is to find a biomarker for Parkinson's disease. A biomarker is an indicator of the presence of a disease, that can be measured, and that is able to give information.

The study will take place in London, in three research sites that are located near to each other. The NIHR Imperial Clinical Research Facility (CRF) at Hammersmith Hospital in London, for clinical assessment, and Invicro London for imaging assessments. Both Hammersmith Hospital and Invicro are located at Hammersmith Hospital Campus.

Taking part in this study will involve two sets of visits spaced out 12 months apart. These visits would include, initial screening and consent visit. The second visit would be for an MRI and PET scan with the tracer BU99008 which highlights astroglia cells. The third visit would be for a SPECT scan, and an optional fourth visit for a Lumbar Puncture procedure to collect spinal fluid for analysis.

These visits are then repeated 12 months later to form a comparison. The maximum number of visits for this study would be 8, however two of these visits are optional lumbar puncture visits.

The findings form this research 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 Parkinson's disease symptoms. n about the progression, or severity, of it.

Study Timeline

• Study Start: 2021-11-01
• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Control	FP-CIT Single-photon Emission Computed Tomography (SPECT) scan	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD patholog
SNCA (Alpha-synuclein gene)	Positron Emission Tomography (PET) scan using BU99008 tracer	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
SNCA (Alpha-synuclein gene)	FP-CIT Single-photon Emission Computed Tomography (SPECT) scan	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
SNCA (Alpha-synuclein gene)	Magnetic Resonance Imaging (MRI) Scan	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
Idiopathic Parkinson's Disease	Positron Emission Tomography (PET) scan using BU99008 tracer	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
Idiopathic Parkinson's Disease	Magnetic Resonance Imaging (MRI) Scan	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
Idiopathic Parkinson's Disease	Lumbar puncture	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
Healthy Control	Magnetic Resonance Imaging (MRI) Scan	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD patholog
SNCA (Alpha-synuclein gene)	Lumbar puncture	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
Idiopathic Parkinson's Disease	FP-CIT Single-photon Emission Computed Tomography (SPECT) scan	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology
Healthy Control	Positron Emission Tomography (PET) scan using BU99008 tracer	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD patholog
Healthy Control	Lumbar puncture	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD patholog

Primary Outcome Measures

Name	Time	Method
Single Photon Emission Computed Tomography (SPECT) to measure brain molecular pathology	12 Months	To quantify serotonergic pathology with BU99008 and dopaminergic pathology with Single-photon Emission Computed Tomography (SPECT)
Magnetic Resonance Imaging (MRI)	12 Months	Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity..
PET scan with BU99008 to highlight I2BS and and Astroglia cells.	12 Months	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

Trial Locations

Locations (1)

University Of Exeter; 🇬🇧 Exeter, Devon, United Kingdom