Back to resultsPET Study in Parkinson's Disease Patients
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
ER tablet 25 mg AZD3241
ER tablet 100 mg AZD3241
Placebo for AZD3241 25 mg
Placebo for AZD3241 100 mg
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson's Disease focused on measuring Phase IIa, AZD3241, microglia activation, safety, Pharmacodynamics and pharmacokinetics analyses, Parkinson patients
Eligibility Criteria
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;
Sites / Locations
- Reserach Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AZD3241
Placebo
Arm Description
AZD3241 tablets 25 mg or 100 mg, titration first 5 days (50 mg bd on Day 1, 100 mg bd on Day 2, 200 mg bd on Day 3, 300 mg bd on Day 4, 400 mg bd on Day 5) Maintenance treatment from Day 6, 600 mg bd until Day 56±3 days
AZD3241 placebo bid for 8 weeks
Outcomes
Primary Outcome Measures
Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET).
Change of binding of [11C]PBR28 to TSPO measured by PET.
Secondary Outcome Measures
Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile.
Change in plasma activity of myeloperoxidase (MPO).
Plasma concentrations of AZD3241.
Part of safety profile in terms of Columbia Suicide Severity Rating Scale.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01527695
Brief Title
PET Study in Parkinson's Disease Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Phase IIa, AZD3241, microglia activation, safety, Pharmacodynamics and pharmacokinetics analyses, Parkinson patients
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD3241
Arm Type
Experimental
Arm Description
AZD3241 tablets 25 mg or 100 mg, titration first 5 days (50 mg bd on Day 1, 100 mg bd on Day 2, 200 mg bd on Day 3, 300 mg bd on Day 4, 400 mg bd on Day 5) Maintenance treatment from Day 6, 600 mg bd until Day 56±3 days
Arm Title
Placebo
Arm Type
Experimental
Arm Description
AZD3241 placebo bid for 8 weeks
Intervention Type
Drug
Intervention Name(s)
ER tablet 25 mg AZD3241
Intervention Description
2 tablets twice daily for Day 1
Intervention Type
Drug
Intervention Name(s)
ER tablet 100 mg AZD3241
Intervention Description
1-6 tablets twice daily from Day 2 until Day 56±3 days
Intervention Type
Drug
Intervention Name(s)
Placebo for AZD3241 25 mg
Intervention Description
2 tablets twice daily for Day 1
Intervention Type
Drug
Intervention Name(s)
Placebo for AZD3241 100 mg
Intervention Description
1-6 tablets twice daily from Day 2 until Day 56±3 days
Primary Outcome Measure Information:
Title
Change of binding [11C]PBR28 to translocator protein (TSPO) measured by Positron Emission Tomography (PET).
Time Frame
baseline, 2-4 weeks
Title
Change of binding of [11C]PBR28 to TSPO measured by PET.
Time Frame
baseline, 7-8 weeks
Secondary Outcome Measure Information:
Title
Adverse events, vital signs, electrocardiogram (ECG), physical examination, clinical chemistry tests, height and weight measures for safety and tolerability profile.
Time Frame
Up to 10 weeks
Title
Change in plasma activity of myeloperoxidase (MPO).
Time Frame
baseline, up to 10 weeks
Title
Plasma concentrations of AZD3241.
Time Frame
Up to 8 weeks
Title
Part of safety profile in terms of Columbia Suicide Severity Rating Scale.
Time Frame
Up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Svenningsson, MD, PHD
Organizational Affiliation
Karolinska University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bjorn Paulsson, MD
Organizational Affiliation
AstraZeneca Medical Science Director
Official's Role
Study Director
Facility Information:
Facility Name
Reserach Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
Facility Name
Research Site
City
Vallingby
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
PET Study in Parkinson's Disease Patients
We'll reach out to this number within 24 hrs