A Randomised, Double-blind, Placebo-controlled, Parallel Design, Multicentre Study in Patients With Mild to Moderate Alzheimer's Disease to Investigate the Effect on Cognitive Function as Measured by Repeated CogState Testing in Relation to Effects on Traditional Cognitive Measures After 12 Weeks

AstraZeneca2 sites in 2 countries155 target enrollmentDecember 2009

ConditionsAlzheimer's Disease

InterventionsDonepezil Placebo to match Aricept

DrugsDonepezil Placebo to match Aricept

Overview

Phase: Early Phase 1
Intervention: Donepezil
Conditions: Alzheimer's Disease
Sponsor: AstraZeneca
Enrollment: 155
Locations: 2
Primary Endpoint: CogState Computerized Neurological Test Battery
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine if there is improvement or measurable change in cognition after only one month of treatment with donepezil when using a computerized test battery. The results at one month will be compared with the results at 3 months to evaluate this.

Registry

clinicaltrials.gov

Start Date

December 2009

End Date

January 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of probable AD according to NINCDS-ADRDA criteria.
•The patient should live with an appropriate caregiver at home, or in a community dwelling. A caregiver should be capable of accompanying the patient to clinic visits or attending study visits in the patient's home.
•Patient and caregiver should understand, speak, and read local language.

Exclusion Criteria

•Significant neurological disease or dementia other than AD, e.g., mixed dementia, frontotemporal dementia, and Parkinson's Disease.
•Females of child bearing potential
•Impaired vision or hearing

Arms & Interventions

1

5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)

Intervention: Donepezil

2

Intervention: Placebo to match Aricept

Outcomes

Primary Outcomes

CogState Computerized Neurological Test Battery

Time Frame: Tl. of 25 times: 10 times between Days 3-14, 5 times between Days 36-42, 5 times between Days 64-70, four times between Days 92-97, 1 time on Day 98

Secondary Outcomes

Neuropsychological Test Battery (NTB)(Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97)
Alzheimer Disease Assessment Scale-Cognitive (ADAS-Cog)(Tl. of 5 times: Once between Days 1-2, Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97)
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC)(Tl. of 4 times: Once anytime between Days 3-14, Once anytime between Days 36-42, Once anytime between Days 64-70, Once between Days 92-97)