Actively Recruiting

Age: 50Years - 85Years
All Genders
Healthy Volunteers
NCT05205291

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

Age: 50Years - 85Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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