The Effect of Cognitive Function as Measured by Repeated Cognitive Measures After 12 Weeks Treatment With Donepezil

Early Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Donepezil; Drug: Placebo to match Aricept

• Registration Number: NCT01024660
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-06
• Last Update Posted: 2011-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Donepezil	5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days)
2	Placebo to match Aricept	-

Primary Outcome Measures

Name	Time	Method
CogState Computerized Neurological Test Battery	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Research Site; 🇿🇦 Roodepoort, South Africa

Reearch Site; 🇨🇦 Quebec, Canada