Trial record 1 of 1 for: d1950c00011

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

This study has been terminated.

(Poor recruitment.)

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT01125683

First received: May 13, 2010

Last updated: May 11, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

May 13, 2010

Last Updated Date

May 11, 2011

Start Date ^ICMJE

June 2010

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01125683 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Alzheimer´s Disease

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
2,5 mg once daily

Intervention: Drug: AZD1446
Active Comparator: 2
single dose of 5 mg

Intervention: Drug: Donepezil
Placebo Comparator: 3
Intervention: Drug: Placebo
Experimental: 4
60 mg once daily

Intervention: Drug: AZD1446
Experimental: 5
60 mg three times daily

Intervention: Drug: AZD1446

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

55 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Russian Federation, Ukraine

Administrative Information

NCT Number ^ICMJE

NCT01125683

Other Study ID Numbers ^ICMJE

D1950C00011, 2010-018273-38

Has Data Monitoring Committee

Responsible Party

MSD, AstraZeneca

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Märta Segerdahl, MD, PhD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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