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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01044342
Enrollment
20
Registered
2010-01-07
Start date
2009-12-31
Completion date
2010-04-30
Last updated
2010-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognition

Keywords

Healthy Volunteers, EEG

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.

Interventions

DRUGAZD1446

capsule; single oral dose

DRUGdonepezil

capsule, single oral dose

DRUGPlacebo

capsule, single oral dose

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
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

Design outcomes

Primary

MeasureTime frame
qEEG assessed through the absolutes alpha-power of the two occipital leadsIn 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

MeasureTime frame
qEEGs/ERPs assessed by mismatch negativity and p300In 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026