Actively Recruiting
Longitudinal Investigation of I2BS in PD
Led by University of Exeter · Updated on 2025-10-07
44
Participants Needed
1
Research Sites
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Longitudinal Investigation of I2BS in PD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide signed informed consent
- Willing and able to comply with scheduled visits and study procedures
- Able to travel to the research sites for study visits
- Aged 25 years or older
- Female participants must be non-childbearing (surgically sterile or post-menopausal) or, if able to bear children, have a negative pregnancy test and not be breastfeeding
- Must use highly effective contraception methods if of childbearing potential or if sexually active male, agree to use condoms and ensure partner uses contraception during the study and for 3 months after last PET or SPECT scan
- Adequate vision and hearing to complete psychological testing
- No use of medications known to interact with I2BS
- Willing and able to stop medications that interfere with dopamine transporter SPECT imaging for at least 5 half-lives before screening
You will not qualify if you...
- Lack capacity to consent as judged by investigator
- Diagnosis of dementia
- Current or recent drug or alcohol abuse or dependence
- Current use of anticoagulants that prevent safe lumbar puncture
- Conditions preventing safe lumbar puncture such as spinal disease or bleeding disorders
- Negative Allen test in both hands
- Use of drugs interfering with dopamine transporter SPECT imaging within 5 months before screening
- Use of medications affecting I2BS
- Use of investigational drugs or devices within 60 days before baseline
- History of cancer within last 5 years except non-metastatic basal cell skin cancer
- Contraindications to MRI such as metal implants or claustrophobia
- Clinically significant medical conditions that may risk safety or affect study completion
- History of suicidal behavior or active suicidal thoughts
- Pregnancy, breastfeeding, or intent to become pregnant within 18 months
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Of Exeter
Exeter, Devon, United Kingdom, EX1 2LU
Actively Recruiting
Research Team
M
Marios Politis, Professor
CONTACT
E
Edoardo de Natale, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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