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

AstraZeneca20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Cognition

Interventions

AZD1446DRUG

capsule; single oral dose

AZD1446DRUG

capsule, single oral dose

donepezilDRUG

capsule, single oral dose

Placebo

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Site

Rouffach, France

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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