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OpenTrials
Completed

NCT Number: NCT01044342

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

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.

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Key information

Conditions

Cognition

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Rouffach, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD1446

Drug

capsule; single oral dose

Donepezil

Drug

capsule, single oral dose

Other names: Aricept

Placebo

Drug

capsule, single oral dose

Primary outcomes

  1. qEEG assessed through the absolutes alpha-power of the two occipital leads

    Time frame: In each treatment period (1, 2, 3, 4) the measure will be taken on Day 1 prior to dosing of AZD1446 or placebo and1h, 2h, 3h, 6h, and 24 hour after dosing of AZD1446 or placebo

Secondary outcomes

  1. qEEGs/ERPs assessed by mismatch negativity and p300

    Time frame: In each treatment period (1, 2, 3, 4) the measure will be taken on Day 1 prior to dosing of AZD1446 or placebo and1h, 2h, 3h, 6h, and 24 hour after dosing of AZD1446 or placebo

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Single-centre, Randomised, Double-blind, Placebo-controlled, Four-period Cross-over Study to Evaluate the Scopolamine Cognition Model in Healthy Male Subjects Using AZD1446 and Donepezil Versus Placebo

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 7, 2010
Registry last updated
May 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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