Clinical Trial of Donepezil Between the Naive Group and the Switching Group

Study Overview
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Brief Summary
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To compare the clinical efficacy of donepezil between the naive group and the switching group.

Detailed Description
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The purposes of this study are: to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil to help to clinicians in choosing the best treatment

Official Title
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Comparative Assessment of Clinical Efficacy of Donepezil Between the Naive Group and the Switching Group

Conditions
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Alzheimer's Disease, Dementia

Intervention / Treatment
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* Drug: donepezil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA Korean version Mini-Mental State Examination scores between 10 and 26 History of cognitive decline that had been gradual in onset and progressive over at least 6 months A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient. Exclusion Criteria: they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease) Psychiatric disorder or severe behavioral disturbances that required psychotropic medications Cerebral injuries induced by trauma, hypoxia, and/or ischemia Clinically active cerebrovascular disease; History of seizure disorder Other physical conditions that required acute treatment.
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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: switching group<br>switching patients with Alzheimer's disease(AD) from galantamine or rivastigmine to donepezil because they were not responding adequately | Drug: donepezil<br>* from 5mg to 10mg, once a day, 12 months<br>* Other names: donepezil-aricept;|
| Experimental: naive group<br>naive patients with AD who initiated therapy with donepezil | Drug: donepezil<br>* from 5mg to 10mg, once a day, 12 months<br>* Other names: donepezil-aricept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K) |  | 13 weeks, 26 weeks, 39 weeks, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seoul Activities of Daily Living (S-ADL) |  | 13 weeks, 26 weeks, 39 weeks, 52 weeks | 
| Seoul-Instrumental Activities of Daily Living (S-IADL) |  | 13 weeks, 26 weeks, 39 weeks, 52 weeks | 
| Korean Neuropsychiatric Inventory (K-NPI) |  | 13 weeks, 26 weeks, 39 weeks, 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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naive group, switching group, treatment response, Efficacy, Adverse event