EUCTR2018-000405-23-FI进行中（未招募）1 期
In vivo PET imaging of neuroinflammation in Parkinson’s disease using the purinergic P2X7 receptor ligand [11C]SMW139 (PRI-PD) - PRI-PD
Juha Rinne / PET Centre0 个研究点目标入组 14 人开始时间: 2018年2月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •HEALTHY VOLUNTEERS
- •1.Subject is between 45 and 80 years (male/female).
- •2.Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs.
- •3.Subject’s body mass index is >18 and <30 kg/m2 with max weight of 100 kg
- •4.Women should be of non-childbearing potential (contraception, postmenopausal, surgically sterile).
- •5.No clinical evidence of a movement disorder as evidenced by careful neurological examination by a neurologist or a MD instructed by a movement disorder specialist.
- •PARKINSON´S DISEASE PATIENTS:
- •1.Subject is between 45 and 80 years (male/female).
- •2.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.
- •3.Subject has a modified Hoehn and Yahr stage = 3.
- •4.Female patients should be of non-childbearing potential (contraception, postmenopausal, surgically sterile).
- •6.No evidence of cognitive impairment.
- •7.Unremarkable MRI scan as assessed by expert radiologist, nuclear medicine physician or neurologist. In subjects < 60 years of age, no clinically significant abnormalities are allowed, in subjects >= 60 years of age white matter hyperintensities corresponding to a WML (white matter lesion) score <= 2 (of 3) on the ARWMC scale are acceptable.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 4
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •HEALTHY VOLUNTEERS
- •1.Subject has a history of any major disease that may interfere with the investigations (especially liver and kidney disease, or uncontrolled diabetes).
- •2.Subject has any history of a major neurological disorder.
- •3.Subject has elevated likelihood for hereditary Parkinson’s disease as assessed by family history.
- •4.Subject has a history or evidence of psychiatric disease, especially depression. A Beck Depression Inventory score should be <= 9.
- •5.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.
- •6.Subject is currently a user (including ‘’recreational use’’) of any illicit drugs, including cannabis, or has a history of drug or alcohol abuse.
- •7.Subject chronically uses anti-inflammatory medication (steroids, non-steroidal anti-inflammatory drugs (NSAID), aspirine, paracetamol, etc.), or other medication known to interact with P2X7 receptors.
- •8.Uncontrolled hypertension juged by the investigator. .
- •9.Previous repetitive use of psychotropic medication.
- •10.Pregnancy or lactation (only for women).
- •11.Administration of any investigational product within 3 months before the start of the present study.
- •12.Known or suspected drug, alcohol or other abuse, or positive urine drug screen which may interfere with the study objective as judged by the investigator.
- •13.History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity as judged by the investigator.
- •14.Subject has a contra-indication for MRI scanning.
- •15.Subject suffers from claustrophobia or cannot tolerate confinement during PET or MR scanning procedures; subject cannot lie still for 90 minutes inside the PET system.
- •16.Subject does not understand the study procedure.
- •17.Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator.
- •18.Subject has a known allergy to xylocaine (which is be used as a local anesthetic for the placement of the arterial catheter).
- •PARKINSON`S DISEASE PATIENTS
- •1.Subject has parkinsonism not caused by idiopathic Parkinson’s disease (e.g. drug-induced, metabolic disorders, encephalitis, vascular parkinsonism, atypical parkinsonian syndromes such as multiple system atrophy, progressive supranuclear palsy and corticobasal degeneration).
- •2.Subject has a history of another major neurological disorder or history of significant brain lesion (e.g. tumor, stroke).
- •3.Subject has significant structural brain lesions on T1 or T2 MRI, unrelated to IPD.
- •4.Subject has a history of any major disease that may interfere with radiotracer investigations (especially severe liver and kidney disease, or uncontrolled diabetes).
- •5.Subject is unable to lie sufficiently still in the PET system, or has tremor with significant head movements.
- •6.Subject consumes excessive alcohol (average > 4 units/day) or has recreational/illicit drug use (including cannabis).
- •7.Subject chronically uses anti-inflammatory medication including systemic steroids.
- •8.Subject has known allergy to lidocaine (which may be used as a local anesthetic for the placement of the arterial catheter).
- •9.Uncontrolled hypertension judged by the investigator. .
- •10.Previous repetitive use of psychotropic medication.
- •11.Pregnancy or lactation (only for women).
- •12.Administration of any investigational product within
研究者
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