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 sites14 target enrollmentFebruary 21, 2018

Overview

No summary available.

Registry

who.int

Start Date

February 21, 2018

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

Juha Rinne / PET Centre

•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\.

•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.