Intensive Instruction on the Use of Aricept

Study Overview
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Brief Summary
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The purpose of this study is to examine the influence of the instruction on the use of Aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.

Detailed Description
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To examine the influence of the instruction on the use of Aricept with educational brochure comparing to the ordinary instruction on the 48-week medication persistence and to assess the reasons for discontinuation.

Official Title
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A Study About the Impact of Intensive Instruction on the Use of Aricept and the Reasons for Discontinuation in Patients With Alzheimer's Disease

Conditions
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Alzheimer's Type Dementia

Intervention / Treatment
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* Behavioral: Intensive adherence instruction
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV. Written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities. Patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution. Outpatients in their own home. Exclusion Criteria: Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment. Known hypersensitivity to donepezil or piperidine derivatives. Involvement in any other investigational drug clinical trail during the preceding 12 weeks.
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive adherence instruction<br>Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure | Behavioral: Intensive adherence instruction<br>* Instruction with educational brochure<br>|
| Sham Comparator: Control<br>The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice. | Behavioral: Control<br>* Instruction as per usual practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Medication Continuation | Number of Participants who Continue the Medication for 48 weeks | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for Discontinuation | Reasons for discontinuation of the Medication | 48 weeks | 
| Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics | Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics | 48 weeks | 
| Adverse Events | Adverse Events for each arm | Week 2, 12, 24, 48 |