A Healthy Volunteer Study to Evaluate Reversibility of Induced Impairment of Cognition

NCT ID: NCT01044342

Last Updated: 2010-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-04-30

Brief Summary

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The purpose of this study is to determine if cognitive impairment induced by scopolamine is reversed using donepezil and/or AZD1446 as compared to placebo, as assessed by electroencephalogram (EEG) measures.

Detailed Description

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Conditions

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Cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Single dose of AZD1446 10 mg

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

capsule; single oral dose

B

Single dose of AZD1446 80 mg

Group Type EXPERIMENTAL

AZD1446

Intervention Type DRUG

capsule, single oral dose

C

Single Dose of Donepezil 5 mg

Group Type ACTIVE_COMPARATOR

donepezil

Intervention Type DRUG

capsule, single oral dose

D

Single dose of placebo to match AZD1446

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

capsule, single oral dose

Interventions

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AZD1446

capsule; single oral dose

Intervention Type DRUG

AZD1446

capsule, single oral dose

Intervention Type DRUG

donepezil

capsule, single oral dose

Intervention Type DRUG

Placebo

capsule, single oral dose

Intervention Type DRUG

Other Intervention Names

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Aricept

Eligibility Criteria

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Inclusion Criteria

* BMI 18-30
* Non-smoker for at least 4 weeks

Exclusion Criteria

* Any clinically relevant acute or chronic disease
* Hypersensitivity to scopolamine
* History of substance abuse
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Locations

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Research Site

Rouffach, , France

Site Status

Countries

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France

Other Identifiers

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D2285M00021

Identifier Type: -

Identifier Source: org_study_id

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