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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Donepezil
* Drug: Donepezil
* Drug: Placebo to match Aricept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>5 mg Donepezil (first 14 days), 10 mg Donepezil (next 70 days) | Drug: Donepezil<br>* 5 mg capsule, orally, once daily, first 14 days of treatment<br>* Other names: Aricept;Drug: Donepezil<br>* 10 mg, orally, once daily, for remaining 70 days of treatment<br>* Other names: Aricept;|
| Placebo Comparator: 2<br> | Drug: Placebo to match Aricept<br>* Placebo capsule, orally, 84 days of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients with Mild to Moderate Alzheimer's Disease