Parkinson's disease
Conditions
Interventions
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion 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
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). - Subjects has an allergy including, but not limited to, hay fever, dust mite allergy and allergies to cats or dogs. - Subjects has asthma ;Additionally for healthy controls: Subject has an elevated likelihood for hereditary Parkinson*s disease as assessed by family history
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the difference in [11C]SMW139 binding between the patient group and the healthy controls, and to identify the optimal tracer kinetic method for quantification of [11C]SMW139 in vivo binding. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary, in the patient group [11C]SMW139 binding will be determined for disease specific regions of interest. A last objective is a possible correlation between [11C]SMW139 binding and clinical motor impairments (UPDRS motor score and modified Hoehn & Yahr stage) in the patient group. | — |
Countries
Belgium, Finland, Germany, Netherlands, Sweden
Outcome results
None listed