PET Study in Parkinson's Disease Patients

Parkinson's Disease Clinical Trial

Official title:

A Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527695
• Other study ID #: D0490C00004
• Status: Completed
• Phase: Phase 2
• First received: December 22, 2011
• Last updated: January 30, 2013
• Start date: April 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyFinland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

This is a multi-centre study to be conducted in Sweden and Finland. Up to 24 male and/or female patients of non-childbearing potential aged 45 to 75 years (inclusive), with a clinical diagnosis Parkinson's Disease will be randomised in the study to allow for 20 patients to complete this study.The study will evaluate the effect of 8 weeks treatment with AZD3241 on microglia activation as measured via PET examinations.

Description:

A Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson's Disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female and male patients aged 45 to 75 years (inclusive) at the day of enrolment (Visit 1)

• Female patients must have a negative pregnancy test at Screening, must not be lactating and must be of non childbearing potential, confirmed at Screening

• 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

• The clinical diagnosis of patients must meet the criteria for "diagnosis of idiopathic Parkinson's disease" according to the modified UKPDS Brain Bank criteria (see Appendix E)

• Modified Hoehn and Yahr stage 1 to 2

Exclusion Criteria:

• 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

• 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

• Presence of significant dyskinesias, motor fluctuations, swallowing difficulties or loss of postural reflexes 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

• 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• ER tablet 25 mg AZD3241
2 tablets twice daily for Day 1
• ER tablet 100 mg AZD3241
1-6 tablets twice daily from Day 2 until Day 56±3 days
• Placebo for AZD3241 25 mg
2 tablets twice daily for Day 1
• Placebo for AZD3241 100 mg
1-6 tablets twice daily from Day 2 until Day 56±3 days

Locations

Country	Name	City	State
Sweden	Reserach Site	Stockholm
Sweden	Research Site	Uppsala
Sweden	Research Site	Vallingby

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET).		baseline, 2-4 weeks	No
Primary	Change of binding of [11C]PBR28 to TSPO measured by PET.		baseline, 7-8 weeks	No
Secondary	Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile.		Up to 10 weeks	Yes
Secondary	Change in plasma activity of myeloperoxidase (MPO).		baseline, up to 10 weeks	No
Secondary	Plasma concentrations of AZD3241.		Up to 8 weeks	No
Secondary	Part of safety profile in terms of Columbia Suicide Severity Rating Scale.		Up to 10 weeks	Yes