PET study in PD patients

• Conditions: Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO; MedDRA version: 14.1Level: LLTClassification code 10013113Term: Disease Parkinson'sSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004803-19-SE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-16
• Last Update Posted: 18 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Female and male patients aged 45 to 75 years (inclusive) at the day of enrolment (Visit 1)
2. Female patients must have a negative pregnancy test at Screening, must not be lactating and must be of non childbearing potential, confirmed at Screening
3. Male patients should be willing to use barrier contraception, eg, condoms, even if their partners are post-menopausal, be surgically sterile or are using accepted contraceptive methods, from the administration of the first dose of the investigational
4. The clinical diagnosis of patients must meet the criteria for diagnosis of idiopathic Parkinson’s disease” according to the modified UKPDS Brain Bank criteria
5. Modified Hoehn and Yahr stage 1 to 2

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 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. Diagnosis is unclear or a suspicion of other Parkinsonian syndromes exists, such as secondary Parkinsonism (caused by drugs, toxins, infectious agents, vascular disease, trauma, brain neoplasm), Parkinson-plus syndromes or heredodegenerative diseases
2. Patients who have undergone surgery for the treatment of Parkinson’s disease (eg, pallidotomy, deep brain stimulation, foetal tissue transplantation) or have undergone any other brain surgery
3. Presence of significant dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes
4. Patients with a history of non-response (according to both the clinician and the patient) to an adequate course of L-dopa or a DA agonist
5. Use of pergolide, selegiline, metoclopramide, strong CYP3A4 inhibitors, CYP3A4 inducers (including St John’s Wort) and strong CYP1A2 inhibitors and inducers, within 1 month of randomisation;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified