NL-OMON44519
Completed
Not Applicable
In vivo imaging of neuroinflammation in Parkinson's disease: A first in human purinergic P2X7 receptor PET study <br> - P2X7R-PD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 14
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •For healthy control subjects:
- •\- Subject is between 45 and 80 years (male/female).
- •\- Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests.
- •\- No clinical evidence of a movement disorder as evidenced by careful neurological examination by a neurologist or an MD instructed by a movement disorder specialist.;For Parkinson's patients:
- •\- Subject is between 45 and 80 years (male/female)
- •\- Subject has a clinical diagnosis of Idiopathic Parkinson\*s Disease (IPD) according to UK PD brain bank criteria, with at least 2 of the cardinal signs of the disease: resting tremor, bradykinesia or rigidity
- •\- Subject has a modified Hoehn and Yahr stage \* 3
Exclusion Criteria
- •\- Subject has parkinsonism not caused by IPD (e.g. drug\-induced, metabolic disorders, encephalitis, vascular PD, atypical PD)
- •\- Subject has a history of another major neurological disorder or history of significant brain lesion (e.g. tumor, stroke)
- •\- Subject has significant structural brain lesions on T1 or T2 MRI, unrelated to IPD.
- •\- Subject has a history of any major disease that may interfere with radiotracer investigations (especially liver and kidney disease, or uncontrolled diabetes).
- •\- Subject chronically uses anti\-inflammatory medication (steroids, non\-steroidal anti\-inflammatory drugs (NSAIDs), aspirine, paracetamol,...)
- •\- Previously subject has had exposure to ionizing radiation (\> 11 mSv) in other research studies within the last 12 months.
- •\- Inability to undergo PET and MRI scans (eg: metal objects in or around the body, claustrophobia or cannot tolerate confinement during PET or MR scanning procedures, unable to lie sufficiently still in the scanner for 90 minutes, or has tremor with significant head movements)
- •\- Subject has had surgery, significant blood loss (\> 500 ml), donated blood or participated in another clinical trial using investigational drug(s) within 30 days prior to the imaging day.
- •\- History of alcohol and/or drug abuse
- •\- Subject has a known allergy to lidocaine (which may be used as a local anesthetic for the placement of the arterial catheter).
Outcomes
Primary Outcomes
Not specified
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