Parkinson DiseaseFOX_1NCT05518617
Molecular and Functional Imaging in Monogenic PD.
An observational study of Parkinson Disease and Nervous System Disorder, run by University of Exeter at 1 site in United Kingdom.
Trial summary
In this study, the investigators aim to 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). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Parkinson Disease, Nervous System Disorder, Neurodegenerative Diseases
- What is being tested?
- Positron Emission Tomography (PET) scan using DASB tracer
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2022to 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 to 80 years
- All sexes
- Adult, Older adult
Study population: A cohort of asymptomatic and symptomatic carriers of genetic mutations for familial forms of Parkinson's Disease, 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.
- 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;
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- 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 serotonergic transmission (e.g. selective serotonin reuptake inhibitors, tricyclic antidepressant, triptans, etc).
- 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 judgement.
- Subjects with a clinical diagnosis of dementia as determined by the investigator.
- Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude 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.
- 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 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).
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- 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 or MRI scanner intolerable.
- Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).
- Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.
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: Molecular and Functional Imaging of Parkinson's Pathology in SNCA, Parkin and PINK1 Mutation Carriers
In this study, the investigators aim to 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 PD symptoms.
Read the 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.
PD is a chronic neurological disease that progresses over time and causes a variety of symptoms, such as slowness of movement, stiffness and shaking. The symptoms of PD are caused by the malfunction and death of vital nerve cells in the brain. it is no known what causes PD and there is no biomarker for it.
Generally, PD occurs without a known cause, and is called sporadic PD. In a few cases, however, PD occurs because of a genetic mutation, and it is called genetic PD. Patients with genetic PD share features to sporadic PD patients. It is believed that studying people who carry mutations for genetic PD mutations would provide precious information on what are the causes of PD and help to devise successful treatments.
Participants will attend 4 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 a SPECT scan. the fourth visit is optional and would be for a lumbar puncture visit. Each visit will last around 6 hours.
- Conditions
- Parkinson Disease, Nervous System Disorder, Neurodegenerative Diseases, Neurodegenerative Disease, Hereditary, Parkinson's
- Being tested
- Positron Emission Tomography (PET) scan using DASB tracer
- Medical subject headings
- Parkinson Disease, Nervous System Diseases, Neurodegenerative Diseases, Heredodegenerative Disorders, Nervous System
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 DASB tracerOther
Also called FP-CIT Single-photon Emission Computed Tomography (SPECT) scan, Magnetic Resonance Imaging (MRI) Scan, Lumbar puncture
DASB is a highly selective PET radioligand for serotonin transporter and is a reliable tool to investigate serotonin terminals and neurons.
The included Magnetic Resonance Imaging (MRI) sequences serve to provide additional information plus complement PET data.
To quantify dopaminergic pathology with [123I]FP-CIT SPECT,
| 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 DASB tracer | |
| Parkin (Parkin 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 DASB tracer | |
| PINK1 (Phosphatase and Tensin Homolog (PTEN)-Induced Kinase 1 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 DASB tracer | |
| GBA1 (Glucosylceramidase beta gene) | Symptomatic and asymptomatic heterozygous carriers of risk variants to the GBA1 gene for Parkinson's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASB (a marker of Serotonin transporter) used to quantify in vivo pathology of serotonin
To quantify serotonergic pathology with [11C]3-amino-4-(2- imethylaminomethylphenylsulfanyl)-benzonitrile (DASB) Positron Emission Tomography (PET)
Measured: 3 weeks
SPECT to measure brain molecular pathology
To quantify serotonergic pathology with [11C]DASB PET and dopaminergic pathology with Single-photon Emission Computed Tomography (SPECT)
Measured: 3 weeks
Magnetic Resonance Imaging (MRI)
Magnetic Resonance Imaging (MRI) to view structural and microstructural changes and structural connectivity.
Measured: 3 weeks
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 Jul 2022
- 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 DiseaseStudies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marios Politits, Professor, Principal investigator, The University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518617
- Sponsor's protocol ID
- 2020-21-14
- Acronym
- FOX_1
- Status last verified
- Oct 2025
- First submitted
- 25 Jul 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
- Molecular and Functional Imaging of Parkinson's Pathology in SNCA, Parkin and PINK1 Mutation Carriers
- ClinicalTrials.gov ID
- NCT05518617
- Acronym / sponsor ID
- FOX_1 / 2020-21-14
- Conditions
- Parkinson Disease, Nervous System Disorder, Neurodegenerative Diseases, Neurodegenerative Disease, Hereditary, Parkinson's
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- 1 Jul 2022 (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 investigators aim to 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 PD 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.
PD is a chronic neurological disease that progresses over time and causes a variety of symptoms, such as slowness of movement, stiffness and shaking. The symptoms of PD are caused by the malfunction and death of vital nerve cells in the brain. it is no known what causes PD and there is no biomarker for it.
Generally, PD occurs without a known cause, and is called sporadic PD. In a few cases, however, PD occurs because of a genetic mutation, and it is called genetic PD. Patients with genetic PD share features to sporadic PD patients. It is believed that studying people who carry mutations for genetic PD mutations would provide precious information on what are the causes of PD and help to devise successful treatments.
Participants will attend 4 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 a SPECT scan. the fourth visit is optional and would be for a lumbar puncture visit. Each visit will last around 6 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SNCA (Alpha-synuclein gene) | – | Other: Positron Emission Tomography (PET) scan using DASB tracerPET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology. |
| Parkin (Parkin gene) | – | Other: Positron Emission Tomography (PET) scan using DASB tracerPET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology |
| PINK1 (Phosphatase and Tensin Homolog (PTEN)-Induced Kinase 1 gene) | – | Other: Positron Emission Tomography (PET) scan using DASB tracerPET and SPECT molecular imaging and MRI; Clinical investigation and computerized neuropsychological testing; Collection of blood, urine and CSF biomarkers of PD pathology |
| GBA1 (Glucosylceramidase beta gene) | – | –Symptomatic and asymptomatic heterozygous carriers of risk variants to the GBA1 gene for Parkinson's disease |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- A cohort of asymptomatic and symptomatic carriers of genetic mutations for familial forms of Parkinson's Disease, and previously collected data from healthy controls.
Key inclusion criteria (16 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.
- 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:
Key exclusion criteria (12 listed)
- Subjects lacking capacity according to investigator judgement.
- Subjects with a clinical diagnosis of dementia as determined by the investigator.
- Current treatment with anticoagulants (e.g. warfarin, heparin) that might preclude 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.
- 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.
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 DASB tracerAlso: FP-CIT Single-photon Emission Computed Tomography (SPECT) scan, Magnetic Resonance Imaging (MRI) Scan, Lumbar punctureDASB is a highly selective PET radioligand for serotonin transporter and is a reliable tool to investigate serotonin terminals and neurons. The included Magnetic Resonance Imaging (MRI) sequences serve to provide additional information plus complement PET data. To quantify dopaminergic pathology with [123I]FP-CIT SPECT, | Other | PINK1 (Phosphatase and Tensin Homolog (PTEN)-Induced Kinase 1 gene), Parkin (Parkin gene), SNCA (Alpha-synuclein gene) |
Primary outcome
DASB (a marker of Serotonin transporter) used to quantify in vivo pathology of serotonin
Time frame: 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
Time frame: 3 weeks
To quantify serotonergic pathology with [11C]DASB PET and dopaminergic pathology with Single-photon Emission Computed Tomography (SPECT)
Magnetic Resonance Imaging (MRI)
Time frame: 3 weeks
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, Project infromationLink 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 Politits, Professor principal investigator
The 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 Disease and Nervous System Disorder, 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 16 inclusion and 12 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 (07503 741242, 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?
DASB (a marker of Serotonin transporter) used to quantify in vivo pathology of serotonin (time frame: 3 weeks). 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.