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

Cognition Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01044342
• Other study ID #: D2285M00021
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2010
• Last updated: May 6, 2010
• Start date: December 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cognition

Intervention

Drug:
• AZD1446
capsule; single oral dose
• AZD1446
capsule, single oral dose
• donepezil
capsule, single oral dose
• Placebo
capsule, single oral dose

Locations

Country	Name	City	State
France	Research Site	Rouffach

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No