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

Recruiting now

Conditions studied: Neurodegenerative Diseases, Parkinson Disease, REM Sleep Behavior Disorder (iRBD)

In brief

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.

Key facts

Study ID: NCT05205291
Run by: University of Exeter
People needed: 30
Starts: 2022-02-28
Expected to finish: 2026-08-31
Last updated by the study team: 2025-10-07

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

40-85 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
BDI-II ≥ 20, moderate depression
No presence or history of inflammatory or autoimmune disorders
Negative family history for neurodegenerative diseases
Cognitively healthy (i.e., education-adjusted MoCA total score ≥ 26 points at screening)
Female subjects must either be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause) or if they are of childbearing potential, they must commit to use of a highly effective contraceptive measure for the duration of the study and a minimum of six months following the PET scan (including combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, or transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, or implantable], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).
Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception during the study and for a minimum of three months following each PET scan (including, for female partners of childbearing potential, combined [estrogen and progestogen containing] hormonal contraception associated with inhibition of ovulation [oral, intravaginal, or transdermal], progestogen-only hormonal contraception associated with inhibition of ovulation [oral, injectable, or implantable], intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).
Male subjects must commit to not donate sperm during the study and for a minimum of three months after the last PET scan.
Individuals must commit to refrain from drinking alcohol for 48 hours before each visit, refrain from drinking any caffeinated substance for 12 hours before the PET-MR visits, and to refrain from smoking or using any nicotine-containing products on the day of the PET-MR scans.
Individuals must commit to not donating blood up to three months after the last PET scan.
Individuals must commit to come to the screening and Day 1 visits in a fasting state (i.e., minimum of 8 hours since last meal/food intake).
Individuals must commit to not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48h before screening visit.
Exclusion Criteria (all):
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
Presence of comorbidities or concomitant medications incompatible with the assessment or imaging procedures as deemed by the study physician
Recent (less than 30 days) use of antipsychotics and corticosteroids
Recent (less than 2 days) use of NSAIDs.
Use of any long-acting benzodiazepines (e.g., diazepam) or use of slow or medium acting benzodiazepines with doses ≥ 30 mg within 30 days prior to the first imaging scan.
Presence of rs6971 genotype of low-affinity binders that hinders the measure of microglial activation with [11C]PBR28 PET

Where it is running

University of Exeter — Exeter, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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