A Multi-national Study to Identify Treatment Discontinuation Rate in de Novo Alzheimer's Disease Patients Who Have Been Newly Prescribed With Donepezil (Aricept) in Asia (ADOS)

Study Overview
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Brief Summary
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This study is an observational study conducted prospectively under routine clinical setting for 1 year with about 700 patients diagnosed as Alzheimer's disease who will be treated by donepezil (Aricept) as monotherapy. The subjects will be recruited in the selected institutions of about 8 countries in Asia.

Detailed Description
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Participation in this study places no additional visit schedule, which will be determined by the investigator's judgment based on the disease progression of each subject. Investigators educate subjects to keep decided visit schedule, and collect the required information for case record from (CRF) on the visit.

Conditions
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Alzheimer's Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to 50 years old and less than 90 years old Diagnosed as probable AD based on NINCDS-ADRDA Patients who have been recently prescribed with donepezil (Aricept) as monotherapy Patients and caregivers who signed the written informed consent from for use of personal and medical information Patients with caregivers who can visit the institution together Exclusion Criteria: 1) Patients who have taken Memantine or Acetylcholinesterase (AChE) inhibitor prior to participating in the study

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 89 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| donepezil (Aricept)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment discontinuation Rate |  | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors leading to donepezil treatment discontinuation | Reason for the subjects who discontinued the administration of donepezil (Aricept) | Up to 1 year | 
| Mean change in treatment duration |  | Up to 1 year | 
| Percent change in treatment regimen |  | Up to 1 year | 
| Mean change in the scores of cognitive assessments test |  | Baseline, Visit 4 [Month 6], and Visit 5: [Year 1] | 
| Compliance of donepezil: Clinical Rating Scale (CRS) | CRS is a compliance scale ranged from 1 to 7. The higher score implies the higher compliance. 5 points or higher is defined as compliance, while 4 points or lower as non-compliance. | Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1] | 
| Compliance of donepezil: Visual Analog Scale (VAS) | VAS is a tool to determine the compliance through interview between investigators and subjects based on drug administration during previous 4 weeks. The range is from 0 to 100. | Baseline, Visit 2 [Month 1], Visit 3 [Month 3], Visit 4 [Month 6], and Visit 5: [Year 1] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease