PET study in Parkinson's Disease patients
Study identifier:D0490C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Parkinson's disease
Phase
Phase 2
Healthy volunteers
No
Study drug
ER tablet 25 mg AZD3241, ER tablet 100 mg AZD3241, Placebo for AZD3241 25 mg, Placebo for AZD3241 100 mg
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
45 Years - 75 Years
Date
Study Start Date: 01 Apr 2012
Primary Completion Date: 01 Dec 2012
Study Completion Date: 01 Jan 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2013 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: AZD3241 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 | Drug: ER tablet 25 mg AZD3241 2 tablets twice daily for Day 1 Drug: ER tablet 100 mg AZD3241 1-6 tablets twice daily from Day 2 until Day 56±3 days |
| Experimental: Placebo AZD3241 placebo bid for 8 weeks | Drug: Placebo for AZD3241 25 mg 2 tablets twice daily for Day 1 Drug: Placebo for AZD3241 100 mg 1-6 tablets twice daily from Day 2 until Day 56±3 days |
Contacts
Investigators
Principal Investigator
Per Svenningsson
Karolinska University Hospital Huddinge, Sweden
