NCT01044342

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 7, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

May 10, 2010

Status Verified

May 1, 2010

Enrollment Period

4 months

First QC Date

January 6, 2010

Last Update Submit

May 6, 2010

Conditions

Cognition

Keywords

Healthy VolunteersEEG

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

Study Arms (4)

A

EXPERIMENTAL

Single dose of AZD1446 10 mg

Drug: AZD1446

B

EXPERIMENTAL

Single dose of AZD1446 80 mg

Drug: AZD1446

C

ACTIVE COMPARATOR

Single Dose of Donepezil 5 mg

Drug: donepezil

D

PLACEBO COMPARATOR

Single dose of placebo to match AZD1446

Drug: Placebo

Interventions

AZD1446DRUG

capsule; single oral dose

A
donepezilDRUG

capsule, single oral dose

Also known as: Aricept
C
PlaceboDRUG

capsule, single oral dose

D

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18-30
  • Non-smoker for at least 4 weeks

You may not qualify if:

  • Any clinically relevant acute or chronic disease
  • Hypersensitivity to scopolamine
  • History of substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Rouffach, France

Location

MeSH Terms

Interventions

3-(5-chloro-2-furoyl)-3,7-diazabicyclo(3.3.0)octaneDonepezil

Intervention Hierarchy (Ancestors)

IndansIndenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 6, 2010

First Posted

January 7, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 10, 2010

Record last verified: 2010-05

Locations

FR(1)