Longitudinal Investigation of I2BS in PD
FOX_2
1 other identifier
observational
44
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
August 24, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
October 7, 2025
October 1, 2025
4.7 years
August 24, 2022
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
12 Months
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)
12 Months
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity..
12 Months
Other Outcomes (9)
Movement Disorder Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
12 Months
Montreal Cognitive Assessment (MOCA) to determine if there is a correlation with neuropsychological and behavioural evaluation
12 Months
Cambridge Neuropsychological Test Automated Battery (CANTAB) to determine if there is a correlation with neuropsychological and behavioural evaluation
12 Months
- +6 more other outcomes
Study Arms (3)
SNCA (Alpha-synuclein gene)
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
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
PET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD patholog
Interventions
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.
A single-photon emission computerized tomography (SPECT) scan allows analysis of brain function by creating 3D Pictures using compounds called tracers.
MRI (magnetic resonance imaging) uses magnets alongside radio waves to create pictures of the brain.
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)
Eligibility Criteria
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
You may qualify if:
- 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.
- 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.
- All subjects must comply with highly effective contraceptive measures. A highly effective contraceptive measure is defined as a measure that can achieve a failure rate of less than 1% per year when used consistently and correctly. These methods are listed in more detail below:
- Oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation;
- Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:
- Intrauterine device (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion
- Vasectomised partner
- Sexual abstinence
- For sexually active male subjects, they must agree to use condoms to protect their partners from becoming pregnant for the duration of the study and for 3 months after the last administration of PET or SPECT ligands. They must also agree to ensure that they and their partners are routinely using a medically approved contraceptive method. It is important that male subjects not impregnate others for the duration of the study and for 3 months after the last administration of PET or SPECT ligands.
- All subjects must have adequate visual and auditory acuity according to investigator's judgement to complete the psychological testing.
- +2 more criteria
You may not qualify if:
- 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.
- Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.
- Negative Allen test in both hands,
- Use of any of the following drugs that might interfere with dopamine transporter SPECT imaging: neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative, within 5 months of Screening.
- Use of any medications with known actions on I2BS (e.g. idaxozan, efaroxan, yohimbine, atomoxetine, atipamezole, mianserin, mirtazapine, clonidine, guanfacine, guanabenz, guanethidine, xylazine, tizanidine, tedetomidine, methyldopa, fadolmidine, dexmedetomidine);
- History of cancer within the last 5 years, with the exception of non-metastatic basal cell carcinoma of the skin.
- Subjects with current or recent history of drug or alcohol abuse/dependence.
- Contraindication to MRI, such as presence of metal devises or implants (e.g. pacemaker, vascular- or heart- valves, stents, clips), metal deposited in the body (e.g. bullets or shells), or metal grains in the eyes;
- Claustrophobia or history of back pain that makes prolonged laying on the PET, SPECT, or MRI scanner intolerable.
- Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
- Presence of any clinically significant medical condition (including cardiovascular, respiratory, cerebrovascular, hematological, hepatic, renal, gastrointestinal, or other disease) that, based on the judgment of the investigator, is clinically unstable, is likely to deteriorate during the course of the study, could put the patient at risk because of participation in the study, could affect the subject's ability to complete the study, or could influence the study results;
- History of suicidal behavior or active suicidal ideation;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Of Exeter
Exeter, Devon, EX1 2LU, United Kingdom
Related Links
Biospecimen
Biosamples collected during this study will be blood, urine, and CSF. Blood biomarkers include routine clinical laboratory, DNA testing, and other analyses.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marios Politis, Professor
University of Exeter
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2022
First Posted
August 26, 2022
Study Start
November 1, 2021
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
October 7, 2025
Record last verified: 2025-10