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Molecular Imaging of Inflammation in Parkinson's Disease Using LPS and TSPO-PET/MR

ConditionsNeurodegenerative DiseasesParkinson DiseaseREM Sleep Behavior Disorder (iRBD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorUniversity of Exeter

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

50-85 years of age, male or female

Able to give informed consent

Adequate visual and auditory acuity to complete the neuropsychological testing

No presence or history of significant neurological or psychiatric disorders

Disqualifiers

Unwilling and/or unable to cooperate with study procedures

Current or a recent (<12 months) history of drug or alcohol abuse/dependence

BDI ≥ 20, moderate depression

Presence of clinically significant (as deemed by the study physician) alterations on safety laboratory blood and urine testing

Trial population

Patients with Parkinson's disease: 18 in total, divided in early drug-naive Parkinson's disease (6); Parkinson's disease in pharmacological therapy(6); Advanced Parkinson's disease (6). Patients with REM sleep behavior disorder: 6 in total; Healthy volunteers (6).

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • Lipopolysaccharide

    Drug

    All participants will receive one dose of Lipopolysaccharide (1ng/Kg) after the first PET/MR scan with \[11C\]PBR28 and four hours before the second PET/MR scan with \[11C\]PBR28.

  • PET/MR with [11C]PBR28

    Radiation

    A PET/MR scan using the tracer \[11C\]PBR28 will be performed to all participants before and four hours after the administration of LPS

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Parkinson's disease patients2 interventions
Group B: Healthy controls2 interventions
Group C: Patients with isolated REM sleep behavior disorder0 interventions

Trial outcomes

Primary outcomes

1

Change in inflammation in the brain following administration of LPS

To evaluate whether the activation of microglia following administration of LPS, as measured with PET/MR and the tracer \[11C\]PBR28, is changed in patients with Parkinson's disease compared with healthy volunteers

Time frame
36 months

Secondary outcomes

1

Correlation of LPS-induced increase of inflammation and cerebral perfusion

To evaluate whether the administration of LPS increases the cerebral perfusion, as measured with Arterial Spin Labelling (ASL) in patients with Parkinson's disease compared with healthy volunteers

Time frame
36 months
2

Correlation of LPS-induced increase of inflammation and resting state functional MRI (rs fMRI)

To evaluate whether the administration of LPS changes resting state functional Magnetic Resonance Imaging (rs-fMRI) parameters, which measure the strength of functional connectivity in the brain, in patients with Parkinson's disease compared with healthy volunteers

Time frame
36 months
3

Safety of LPS administration in Parkinson's disease patients

To evaluate whether the administration of LPS is safe to use as a paradigm of in vivo study of inflammation in patient with Parkinson's disease, as measured by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and by overnight monitoring of the participants.

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Exeter

Lead sponsor

Source ClinicalTrials.gov
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