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Longitudinal Investigation of I2BS in PD

Sponsor: University of Exeter

NCT ID: NCT05516719

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
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 (other)
How long the study runs
Study runs about 55 months (dates as stated)
About the drug or intervention
Positron Emission Tomography (PET) scan using BU99008 tracer — other: 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) scan — other: 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) Scan — other: MRI (magnetic resonance imaging) uses magnets alongside radio waves to create pictures of the brain. · Lumbar puncture — other: A lumbar puncture is where a thin needle is inserted between the bones in your lower spine using local anaesthetic.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
25 Years and over
Who
All
Number of participants
44
Started
2021-11-01
Last checked
2025-10

Plain English Summary

What is this study?

  • • Testing a new treatment for parkinson's
  • • Clinical study - 44 participants
  • • In this study, the researchers aim to find a biomarker of PD

Who can take part?

  • • Ages 25 Years and over
  • • Diagnosed with parkinson's

Where?

  • • Exeter - University Of Exeter

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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

More detail

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.

Parkinson'sParkinson DiseaseParkinson's DiseaseNeurodegenerative DiseasesNeurodegenerationPositron Emission Tomography

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 25 Years and over
  • Who can join: All genders

Biomarkers mentioned

demonstrated by negative

Treatment history

Treatments you must have had:

  • ✓ study procedures and laboratory tests
  • ✓ no use of medications with known interaction with I2BS (e

What the study is looking for

  • ✓Inclusion criteria
  • ✓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.
  • ✓Oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated...
See the full criteria
Inclusion criteria * 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. * 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. Exclusion criteria * 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); * 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;

Where Is This Study? (1 UK site)

University Of Exeter

Exeter EX1 2LU, United Kingdom

Recruiting
Site contact (verified)
Marios Politis, Professor07503 741242m.politis@exeter.ac.uk

How to Get in Touch

Marios Politis, Professor

Sponsor contact

CONTACT

07503741242 M.Politis@exeter.ac.uk

Edoardo de Natale, Dr

Sponsor contact

CONTACT

07503741242 e.de-natale@exeter.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-10