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

May 11, 2011 updated by: AstraZeneca

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 3
Drug: Placebo
Capsule, oral and single dose
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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

Outcome Measure
Time Frame
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.
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
Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study.
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.
Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study.
Information on these will be collected from the time of informed consent is signed, throughout the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Märta Segerdahl, MD, PhD, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria

May 17, 2010

First Posted (ESTIMATE)

May 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 13, 2011

Last Update Submitted That Met QC Criteria

May 11, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1950C00011
  • 2010-018273-38 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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