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

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ClinicalTrials.gov Identifier: NCT01044342
Recruitment Status : Completed
First Posted : January 7, 2010
Last Update Posted : May 10, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Cognition Drug: AZD1446 Drug: donepezil Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : December 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01044342


Locations
France
Research Site
Rouffach, France
Sponsors and Collaborators
AstraZeneca

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01044342     History of Changes
Other Study ID Numbers: D2285M00021
First Posted: January 7, 2010    Key Record Dates
Last Update Posted: May 10, 2010
Last Verified: May 2010

Keywords provided by AstraZeneca:
Healthy Volunteers
EEG

Additional relevant MeSH terms:
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents