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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: January 6, 2010
Last updated: May 6, 2010
Last verified: May 2010
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
Drug: AZD1446
Drug: donepezil
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (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

Resource links provided by NLM:

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 ]

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 ]

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


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01044342

Research Site
Rouffach, France
Sponsors and Collaborators
  More Information

Responsible Party: MSD, AstraZeneca Identifier: NCT01044342     History of Changes
Other Study ID Numbers: D2285M00021
Study First Received: January 6, 2010
Last Updated: May 6, 2010

Keywords provided by AstraZeneca:
Healthy Volunteers

Additional relevant MeSH terms:
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents processed this record on May 25, 2017