To Evaluate Effects of AZD1446, Placebo and Donepezil in Patients With Alzheimer's Disease

Alzheimer´s Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01125683
• Other study ID #: D1950C00011
• Secondary ID: 2010-018273-38
• Status: Terminated
• Phase: Phase 2
• First received: May 13, 2010
• Last updated: May 11, 2011
• Start date: June 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether treatment with single and multiple oral doses of AZD1446 for 1 week will have effect on Quantified Electroencephalography and Event-Related Potentials in patients with Alzheimers Disease. The total treatment period is 9 weeks, divided into 5 equally long sub-periods of 7 days and 4 wash-out periods of 7 days each.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of probable Alzheimer´s Disease

• Hachinski Ischaemic score < 4

• MSE score 18 to 24

Exclusion Criteria:

• History of any clinically significant disease or dementia other than Alzheimer´s Disease

• Current major depressive disorder or other major psychiatric disorders

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer´s Disease

Intervention

Drug:
• AZD1446
Capsule, oral single and multiple dose
• Donepezil
Capsule, oral and single dose
• Placebo
Capsule, oral and single dose

Locations

Country	Name	City	State
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Kiev
Ukraine	Research Site	Lugansk
Ukraine	Research Site	Vinnytsia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of single and multiple dosing of AZD1446 and a single dose of donepezil on Quantified electroencephalography (qEEG) and Event-related potentials (ERP) in patients with mild-to-moderate AD.		collected from the time of informed consent is signed, throughout the study. The total study period is 9 weeks, divided into 5 equally long treatment periods of 7 days and 4 wash-out periods of 7 days each.
Secondary	To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.		Information on these will be collected from the time of randomization, throughout the study.
Secondary	To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable		Information on these will be collected from the time of informed consent is signed, throughout the study.
Secondary	Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.		Information on these will be collected from the time of informed consent is signed, throughout the study.