Serotonin Release in Premotor and Motor PD

Recruiting

• Conditions: Parkinson Disease; Parkinson's; Parkinson's Disease; Neurodegeneration; Positron Emission Tomography; Neurodegenerative Diseases
• Interventions: Other: Positron Emission Tomography (PET) scan using CIMBI-36 tracer; Other: Magnetic Resonance Imaging (MRI) Scan; Other: Positron Emission Tomography (PET) scan using DASB tracer; Other: FP-CIT Single-photon Emission Computed Tomography (SPECT) scan; Other: Lumbar puncture

• Registration Number: NCT05516732
• Lead Sponsor: University of Exeter

Brief Summary

In this study, the investigators aim to provide a deeper understanding of Parkinson's disease and 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 Parkinson's disease symptoms

Detailed Description

The purpose of this study is to find a biomarker for Parkinson's disease (PD). A biomarker is an indicator of the presence of a disease, that can be measured, and that is able to give information about the progression, or severity, of it.

The study visits will take place in London. There are three locations on Hammersmith hospital campus, that are located near to each other. The NIHR Imperial Clinical Research Facility and Invicro London for clinical and MRI and PET assessments, and Imperial Healthcare Nuclear Medicine Department for the SPECT scan.

Participants will attend 5 visits in a 3 month period. These visits include an initial consent and assessment visit where some blood samples will also be taken. The second visit involves a PET scan with the tracer DASB along with an MRI scan. The third visit involves two PET scans one in the morning, with CIMBI tracer, an injection of Dexamphetamine, and then a second with CIMBI tracer to make a comparison. The fourth visit involves a SPECT scan, and the fifth visit is optional and would be for a lumbar puncture visit. Each visit will last around 6 hours.

Study Timeline

• Study Start: 2022-07-01
• 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: 42

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
SNCA (Alpha-synuclein gene)	Positron Emission Tomography (PET) scan using CIMBI-36 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)	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
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
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
SNCA (Alpha-synuclein gene)	Positron Emission Tomography (PET) scan using DASB 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
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	Positron Emission Tomography (PET) scan using CIMBI-36 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	Positron Emission Tomography (PET) scan using DASB tracer	PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology

Primary Outcome Measures

Name	Time	Method
Magnetic Resonance Imaging (MRI)	3 Weeks	Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity.
CIMBI to measure serotonin release	3 weeks	CIMBI-36 can be interpreted to show serotonin release capacity both quantifiably and locational.
DASB (a marker of Serotonin transporter) used to quantify in vivo pathology of serotonin	3 Weeks	To quantify serotonergic pathology with \[11C\]3-amino-4-(2- imethylaminomethylphenylsulfanyl)-benzonitrile (DASB) Positron Emission Tomography (PET)
SPECT to measure brain molecular pathology	3 Weeks	To quantify serotonergic pathology with \[11C\]DASB PET and dopaminergic pathology with Single-photon Emission Computed Tomography (SPECT)

Trial Locations

Locations (1)

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