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

Primary Purpose

Alzheimer´s Disease

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AZD1446

Donepezil

Placebo

About this trial

This is an interventional basic science trial for Alzheimer´s Disease focused on measuring Phase II, Alzheimer's disease, EEG, cognition, pharmacodynamic

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Experimental

Arm Label

Arm Description

2,5 mg once daily

single dose of 5 mg

60 mg once daily

60 mg three times daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To measure the relationship between plasma concentration of AZD1446/donepezil and qEEG and ERP.

To evaluate the correlation between changes in qEEG/ERP and changes in cognition, if applicable

Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology, Urinalysis and Physical Examination.

Full Information

NCT ID

NCT01125683

First Posted

May 13, 2010

Last Updated

May 11, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01125683

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Terminated

Why Stopped

Poor recruitment.

Study Start Date

June 2010 (undefined)

Primary Completion Date

March 2011 (Actual)

Study Completion Date

March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer´s Disease

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

2,5 mg once daily

Arm Title

Arm Type

Active Comparator

Arm Description

single dose of 5 mg

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Description

60 mg once daily

Arm Title

Arm Type

Experimental

Arm Description

60 mg three times daily

Intervention Type

Drug

Intervention Name(s)

AZD1446

Intervention Description

Capsule, oral single and multiple dose

Intervention Type

Drug

Intervention Name(s)

Donepezil

Intervention Description

Capsule, oral and single dose

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Capsule, oral and single dose

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

Title

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.

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Märta Segerdahl, MD, PhD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Kazan

Country

Russian Federation

Facility Name

Research Site

City

Moscow

Country

Russian Federation

Facility Name

Research Site

City

St. Petersburg

Country

Russian Federation

Facility Name

Research Site

City

Dnipropetrovsk

Country

Ukraine

Facility Name

Research Site

City

Kiev

Country

Ukraine

Facility Name

Research Site

City

Lugansk

Country

Ukraine

Facility Name

Research Site

City

Vinnytsia

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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