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Terminated/Withdrawn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, AZD1446, 2.5 mg od, AZD1446, 2.5 mg od, AZD1446, 2.5 mg od, AZD1446, 2.5 mg od, AZD1446, 2.5 mg od, AZD1446, 2.5 mg od, AZD1446, 2.5 mg od, AZD1446, 2.5 mg od, AZD1446, 2.5 mg od, Donepezil, Donepezil, Donepezil, Donepezil, Donepezil, Donepezil, Donepezil, Donepezil, Donepezil, Donepezil, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, Placebo, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446 60 mg od, AZD1446, 60 mg tid, AZD1446, 60 mg tid, AZD1446, 60 mg tid, AZD1446, 60 mg tid, AZD1446, 60 mg tid, AZD1446, 60 mg tid, AZD1446, 60 mg tid, AZD1446, 60 mg tid, AZD1446, 60 mg tid, 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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| 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
