To evaluate effects of AZD1446, Placebo and Donepezil in patients with Alzheimer's Disease
Study identifier:D1950C00011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:2010-018273-38
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Pharmacodynamic Effect of Single and Multiple Oral Doses of AZD1446/ Placebo and a Single Dose of Donepezil on Quantified Electroencephalography and Event-Related Potentials in Patients with AD
Medical condition
Alzheimer´s disease
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD1446, 2.5 mg od, Donepezil, Placebo, AZD1446 60 mg od, AZD1446, 60 mg tid
Sex
All
Actual Enrollment
35
Study type
Interventional
Age
55 Years - 85 Years
Date
Study Start Date: 01 Jun 2010
Primary Completion Date: 01 Mar 2011
Study Completion Date: 01 Mar 2011
Study design
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2014 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sequence 1 First 2.5mg od, then 60mg od, then Placebo, then 60mg tid, then Donepezil 5mg | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 2 First 2.5mg od, then Placebo, then 60mg od, then Donepezil 5 mg, then 60mg tid | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 3 First 60mg od, then 2.5mg od, then 60mg tid, then Placebo, then Donepezil 5mg | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 4 First 60mg od, then 60mg tid, then 2.5mg od, then Donepezil 5mg, then Placebo | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 5 First 60mg tid, then 60mg od, then Donepezil 5mg, then 2.5mg od, then Placebo | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 6 First 60 mg tid, then Donepezil 5 mg, then 60 mg od, then Placebo, then 2.5 mg od | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 7 First Donepezil 5 mg, then 60 mg tid, then Placebo, then 60 mg od, then 2.5 mg od | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 8 First Donepezil 5 mg, then Placebo, then 60 mg tid, then 2.5 mg od, then 60 mg od | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 9 First Placebo, then 2.5 mg od, then Donepezil 5 mg, then 60 mg od, then 60 mg tid | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
| Experimental: Sequence 10 First Placebo, then Donepezil 5 mg, then 2.5 mg od, then 60 mg tid, then 60 mg od | Drug: AZD1446, 2.5 mg od Capsule, oral 2.5 mg dose, once daily Drug: Donepezil Capsule, oral and single 5 mg dose Drug: Placebo Capsule, oral and single dose Drug: AZD1446 60 mg od Capsule, oral 60 mg dose once daily Drug: AZD1446, 60 mg tid Capsule, oral 60 mg dose three times a day |
Contacts
Investigators
Principal Investigator
Märta Segerdahl
AstraZeneca
