Parkinson'sFOX_2NCT05516719
Longitudinal Investigation of I2BS in PD
An observational study of Parkinson's and Parkinson Disease, run by University of Exeter at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's, Parkinson Disease, Parkinson's Disease
- What is being tested?
- Positron Emission Tomography (PET) scan using BU99008 tracer, FP-CIT Single-photon Emission Computed Tomography (SPECT) scan and Magnetic Resonance Imaging (MRI) Scan
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2021to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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
Who may be able to join
- 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:
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- 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.
- All subjects must have no use of medications with known interaction with I2BS (e.g. idaxozan, efaroxan, yohimbine, atomoxetine, atipamezole, mianserin, mirtazapine, clonidine, guanfacine, guanabenz, guanethidine, xylazine, tizanidine, tedetomidine, methyldopa, fadolmidine, dexmedetomidine)
- For subjects taking any drugs that might interfere with dopamine transporter SPECT imaging (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivative) must be willing and able from a medical standpoint to hold the medication for at least 5 half-lives prior to screening DaTSCANä imaging.
Who cannot join
- 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,
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- 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);
- Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a clinical trial are not exclusionary, e.g., coenzyme Q10).
- 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;
- Pregnancy or breastfeeding or intent to become pregnant in the next 18 months;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Of Exeter
Exeter, Devon, EX1 2LU
Marios Politis, Professor, 07503 741242, m.politis@exeter.ac.uk
Edoardo de Natale, Dr, 07503 741242, e.de-natale@exeter.ac.uk
About this study
Official title: Longitudinal Investigation of Imidazoline-2 Binding Site as a Novel Marker of Disease Progression in Parkinson's Disease: An [11C]BU99008 PET Study
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
Read the 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.
- Conditions
- Parkinson's, Parkinson Disease, Parkinson's Disease, Neurodegenerative Diseases, Neurodegeneration, Positron Emission Tomography
- Being tested
- Positron Emission Tomography (PET) scan using BU99008 tracer, FP-CIT Single-photon Emission Computed Tomography (SPECT) scan, Magnetic Resonance Imaging (MRI) Scan, Lumbar puncture
- Medical subject headings
- Parkinson Disease, Neurodegenerative Diseases, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positron Emission Tomography (PET) scan using BU99008 tracerOther
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) scanOther
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) ScanOther
MRI (magnetic resonance imaging) uses magnets alongside radio waves to create pictures of the brain.
Lumbar punctureOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 | |
| 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 Receives: 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 | |
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 12 Months
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity..
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Nov 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson'sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marios Politis, Professor, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516719
- Sponsor's protocol ID
- 2020-21-15
- Acronym
- FOX_2
- Status last verified
- Oct 2025
- First submitted
- 24 Aug 2022
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yet to be confirmed
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Investigation of Imidazoline-2 Binding Site as a Novel Marker of Disease Progression in Parkinson's Disease: An [11C]BU99008 PET Study
- ClinicalTrials.gov ID
- NCT05516719
- Acronym / sponsor ID
- FOX_2 / 2020-21-15
- Conditions
- Parkinson's, Parkinson Disease, Parkinson's Disease, Neurodegenerative Diseases, Neurodegeneration, Positron Emission Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SNCA (Alpha-synuclein gene) | – | 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 puncturePET 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 | – | 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 puncturePET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology |
| Healthy Control | – | 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 puncturePET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD patholog |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positron Emission Tomography (PET) scan using BU99008 tracerA 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. | Other | Healthy Control, Idiopathic Parkinson's Disease, SNCA (Alpha-synuclein gene) |
| FP-CIT Single-photon Emission Computed Tomography (SPECT) scanA single-photon emission computerized tomography (SPECT) scan allows analysis of brain function by creating 3D Pictures using compounds called tracers. | Other | Healthy Control, Idiopathic Parkinson's Disease, SNCA (Alpha-synuclein gene) |
| Magnetic Resonance Imaging (MRI) ScanMRI (magnetic resonance imaging) uses magnets alongside radio waves to create pictures of the brain. | Other | Healthy Control, Idiopathic Parkinson's Disease, SNCA (Alpha-synuclein gene) |
| Lumbar punctureA 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) | Other | Healthy Control, Idiopathic Parkinson's Disease, SNCA (Alpha-synuclein gene) |
Primary outcome
PET scan with BU99008 to highlight I2BS and and Astroglia cells.
Time frame: 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
Single Photon Emission Computed Tomography (SPECT) to measure brain molecular pathology
Time frame: 12 Months
To quantify serotonergic pathology with BU99008 and dopaminergic pathology with Single-photon Emission Computed Tomography (SPECT)
Magnetic Resonance Imaging (MRI)
Time frame: 12 Months
Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity..
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- University of Exeter brief project information webpageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Yet to be confirmed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marios Politis, Professor principal investigator
University of Exeter
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's and Parkinson Disease, run by University of Exeter at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marios Politis, Professor (07503741242, M.Politis@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET scan with BU99008 to highlight I2BS and and Astroglia cells. (time frame: 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.