4 week, Safety and Tolerability study in Patients with Mild to Moderate Alzheimer's Disease - ROBIN
Study identifier:D1950C00006
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Safety, Tolerability and Pharmacokinetics of 3 Dose regimens of AZD1446 vs. Placebo as an Add-on Treatment to Donepezil: A Multi-centre, Double-blind, Randomised, Placebo controlled, Parallel group Phase IIa Study in Patients with Mild to Moderate Alzheimer’s Disease during 4 weeks of Treatment
Medical condition
Alzheimer's disease
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD1446, Placebo
Sex
All
Actual Enrollment
99
Study type
Interventional
Age
60 Years - 85 Years
Date
Study Start Date: 01 Dec 2009
Primary Completion Date: 01 Jul 2010
Study Completion Date: 01 Jul 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 AZD1446 60mg once daily + donepezil 10mg | Drug: AZD1446 capsules, oral, 3 times daily |
| Experimental: 2 AZD1446 60mg three times daily + donepezil 10mg | Drug: AZD1446 capsules, oral, 3 times daily |
| Experimental: 3 AZD1446 30mg three times daily + donepezil 10mg | Drug: AZD1446 capsules, oral, 3 times daily |
| Placebo Comparator: 4 placebo + donepezil 10mg | Drug: Placebo capsules, oral, 3 times daily, 4 weeks |
