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Molecular and Functional Imaging in Monogenic PD.

Sponsor: University of Exeter

NCT ID: NCT05518617

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 DASB tracer (other)
How long the study runs
Study runs about 47 months (dates as stated)
About the drug or intervention
Positron Emission Tomography (PET) scan using DASB tracer — other: DASB is a highly selective PET radioligand for serotonin transporter and is a reliable tool to investigate serotonin terminals and neurons.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
25 Years to 80 Years
Who
All
Number of participants
45
Started
2022-07-01
Last checked
2025-10

Plain English Summary

What is this study?

  • • Testing a new treatment for parkinson disease
  • • Clinical study - 45 participants
  • • In this study, the investigators aim to find a biomarker of Parkinson's disease

Who can take part?

  • • Ages 25 Years to 80 Years
  • • Diagnosed with parkinson disease

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 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.

More detail

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.

Parkinson DiseaseNervous System DisorderNeurodegenerative DiseasesNeurodegenerative Disease, HereditaryParkinson's

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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 - 80 Years
  • 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 serotonergic transmission (e

What the study is looking for

  • ✓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.
  • ✓Oral, intravaginal, or transdermal combined (estrogen and progestogen containing) hormonal contraception associated...
  • ✓Oral, injectable, or implantable progestogen-only hormonal contraception associated with inhibition of ovulation:
  • ✓Intrauterine device (IUD)

Who cannot take part

  • ✗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...
  • ✗Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease,...
  • ✗Use of investigational drugs or devices within 60 days prior to Baseline (dietary supplements taken outside of a...
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. * 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 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. Exclusion Criteria: * 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). * 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.

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

07503 741242 m.politis@exeter.ac.uk

Edoardo de Natale, Dr

Sponsor contact

CONTACT

07503 741242 e.de-natale@exeter.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-10