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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01044342
First received: January 6, 2010
Last updated: May 6, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Cognition
 Drug: AZD1446
Drug: donepezil
Drug: Placebo
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Single dose of AZD1446 10 mg
 Drug: AZD1446
capsule; single oral dose
Experimental: B
Single dose of AZD1446 80 mg
 Drug: AZD1446
capsule, single oral dose
Active Comparator: C
Single Dose of Donepezil 5 mg
 Drug: donepezil
capsule, single oral dose
Other Name: Aricept
Placebo Comparator: D
Single dose of placebo to match AZD1446
 Drug: Placebo
capsule, single oral dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044342

Locations
France
Research Site
Rouffach, France
Sponsors and Collaborators
AstraZeneca
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01044342     History of Changes
Other Study ID Numbers: D2285M00021
Study First Received: January 6, 2010
Last Updated: May 6, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AstraZeneca:
Healthy Volunteers
EEG

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
 Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013