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

Phase 2

Terminated

• Conditions: Alzheimer´s Disease
• Interventions: Drug: AZD1446; Drug: Placebo; Drug: Donepezil

• Registration Number: NCT01125683
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-17
• Study First Posted: 2010-05-18
• Study Start: 2010-06
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-11
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4	AZD1446	60 mg once daily
1	AZD1446	2,5 mg once daily
3	Placebo	-
5	AZD1446	60 mg three times daily
2	Donepezil	single dose of 5 mg

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Research Site; 🇺🇦 Vinnytsia, Ukraine