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

Phase 1

Completed

• Conditions: Cognition
• Interventions: Drug: AZD1446; Drug: Placebo; Drug: donepezil

• Registration Number: NCT01044342
• Lead Sponsor: AstraZeneca

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-01-06
• Study First Submitted QC: 2010-01-06
• Study First Posted: 2010-01-07
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-06
• Last Update Posted: 2010-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	AZD1446	Single dose of AZD1446 10 mg
B	AZD1446	Single dose of AZD1446 80 mg
D	Placebo	Single dose of placebo to match AZD1446
C	donepezil	Single Dose of Donepezil 5 mg

Primary Outcome Measures

Name	Time	Method
qEEG assessed through the absolutes alpha-power of the two occipital leads	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 Outcome Measures

Name	Time	Method
qEEGs/ERPs assessed by mismatch negativity and p300	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

Trial Locations

Locations (1)

Research Site; 🇫🇷 Rouffach, France