Actively Recruiting
Molecular Imaging of Inflammation in Parkinson's Disease Using LPS and TSPO-PET/MR
Led by University of Exeter · Updated on 2025-10-07
30
Participants Needed
1
Research Sites
235 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
It is not known what causes Parkinson's disease and what makes it worsen over time. Research conducted in the past few years has highlighted the possible role of inflammation on this process but its actual mechanisms are still obscure. In this study, the investigators aim to gain understanding on how inflammation is increased in Parkinson's disease and what are its mechanisms, by performing two Positron Emission Tomography (PET) scans using the tracer \[11C\]PBR28, that takes pictures of the brain highlighting the areas of inflammation, before and after the administration of a compound called Lipopolysaccharide or LPS, that is known to cause a mild degree of inflammation. The investigators will couple this study with two venous blood draws to measure the levels of circulating molecules of inflammation.
CONDITIONS
Official Title
Molecular Imaging of Inflammation in Parkinson's Disease Using LPS and TSPO-PET/MR
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 50 to 85 years, male or female
- Able to provide informed consent
- Adequate vision and hearing to complete neuropsychological tests
- No significant neurological or psychiatric disorders
- Moderate depression (BDI 60; 20)
- No inflammatory or autoimmune disorders
- Negative family history for neurodegenerative diseases
- Cognitively healthy with MoCA score 60; 26
- For women: surgically sterile, post-menopausal for at least 1 year, or using effective contraception
- For men and partners of childbearing potential: use effective contraception during and after the study
- Commitment to avoid alcohol, caffeine, nicotine as specified before visits
- Commitment to fasting before screening and Day 1 visits
- Commitment to avoid NSAIDs and alcohol 48 hours before screening
- Parkinson's disease patients must meet diagnostic criteria and therapy status as specified
- Participants with PD-MCI must meet defined diagnostic criteria
- Participants with iRBD aged 40-85, meeting similar criteria
You will not qualify if you...
- Unwilling or unable to comply with study procedures
- Current or recent (within 12 months) drug or alcohol abuse
- Moderate depression (BDI 60; 20)
- Significant abnormalities in safety lab tests
- Comorbidities or medications interfering with assessments
- Recent use of antipsychotics, corticosteroids, NSAIDs
- Use of certain benzodiazepines within 30 days prior to imaging
- Low-affinity binders for PET tracer
- Neurological disorders or brain lesions
- Positive serology for HIV, syphilis, SARS-CoV2, or hepatitis
- History of autonomic dysfunction or bradycardia
- Pregnancy or breastfeeding
- MRI contraindications such as metal implants
- Recent cancer history except specific treated cases
- Claustrophobia or back pain preventing scans
- Contraindications to arterial cannulation
- Negative Allen's test for hand blood flow
- Recent infection or vaccination within 30 days
- Participation in other clinical trials testing investigational drugs
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Exeter
Exeter, United Kingdom
Actively Recruiting
Research Team
E
Edoardo R. de Natale, MD MSc Ph.D
CONTACT
H
Heather Wilson, MSc Ph.D
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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