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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer´s Disease	Drug: AZD1446; Drug: Donepezil; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Basic Science
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
Study Start Date :	June 2010
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; 2,5 mg once daily	Drug: AZD1446; Capsule, oral single and multiple dose
Active Comparator: 2; single dose of 5 mg	Drug: Donepezil; Capsule, oral and single dose
Placebo Comparator: 3	Drug: Placebo; Capsule, oral and single dose
Experimental: 4; 60 mg once daily	Drug: AZD1446; Capsule, oral single and multiple dose
Experimental: 5; 60 mg three times daily	Drug: AZD1446; Capsule, oral single and multiple dose

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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. [ Time Frame: 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 :

1. To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP. [ Time Frame: Information on these will be collected from the time of randomization, throughout the study. ]
2. To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable [ Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study. ]
3. Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination. [ Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study. ]

Eligibility Criteria

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Ages Eligible for Study:	55 Years to 85 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Russian Federation
Research Site
Kazan, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
St. Petersburg, Russian Federation
Ukraine
Research Site
Dnipropetrovsk, Ukraine
Research Site
Kiev, Ukraine
Research Site
Lugansk, Ukraine
Research Site
Vinnytsia, Ukraine

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Märta Segerdahl, MD, PhD	AstraZeneca

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01125683 History of Changes
Other Study ID Numbers:	D1950C00011; 2010-018273-38 ( EudraCT Number )
First Posted:	May 18, 2010
Last Update Posted:	May 13, 2011
Last Verified:	May 2011

Keywords provided by AstraZeneca:

Phase II; Alzheimer's disease; EEG; cognition; pharmacodynamic

Additional relevant MeSH terms:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders	Donepezil; Cholinesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Nootropic Agents