Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.

Detailed Description
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This study is a multi-center, single-arm, open labeling clinical trial, which the objective is to evaluate the safety and Efficacy of donepezil in Alzheimer's disease( AD) patients in China, and investigate the relationship between Apo-E gene type with adverse events of donepezil.

Official Title
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Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Donepezil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 ≤ years of age < 85years. Patients newly diagnosed as probable AD based on NINCDS- ADRDA (1984); Mild to moderate AD with MMSE10-24, modified Hachinski ischaemic scale (MHIS)≤4, ADL≥23,HAMD<7. MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2). 5mg daily of Donepezil for at least four weeks before enrollment. Patient with exclusive caregiver. Move freely with or without walking aid. With good eyesight and hearing, can cooperate with the examination and treatment. Patient and caregiver who signed the written informed consent form for the terms of personal and medical information. Exclusion Criteria: With Vascular dementia or other types of dementia. Accompanied by other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc). With type I diabetes, obstructive lung disease or asthma, vitamin B12 or folic acid deficiency, thyroid dysfunction, severe liver or kidney dysfunction, severe cardiac insufficiency (congestive heart-failure, myocardial infarction, Sick Sinus Syndrome, II-III degree atrioventricular block or heart rate<50bpm). Epilepsy or head trauma resulted in unconsciousness once occured in the past two years. Blood diseases (such as anemia, granulocytes, leukemia, etc) or tumor 5. With Hematologic Disease or neoplasms within past 2 years. Has a history of alcohol dependence and drug abuse. With known hypersensitivity to medicines or foods. Taking anticholinergic agents or antihistaminic agents. Patients who had been hospitalized continuously for more than 3 months before screening.

Ages Eligible for Study
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Minimum Age: 50 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: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: multi-center, single-arm, open labeling clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: donepezil<br>This is a multi-center single-arm study, which assess the safety and efficacy of donepezil in mild to moderate Alzheimer's disease in China. | Drug: Donepezil<br>* Eligible patients is treated with Aricept® 10 mg/day for 20 weeks of study period. Aricept® should be taken at night, just prior to sleeping. If patient cannot endure 10mg/d，the patient can reduce to 5mg/d for 4 weeks and then increase back to 10mg/d. Patients who cannot endure the 10mg/d titration of 2nd time and then back to 5mg/d or discontinuance of Aricept® should be regarded as to quit the study. There will be a visting at week 0, the end of week 4 and the end of week 20 ,respectively.<br>* Other names: Aricept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitoring and recording the count and incidence of adverse events (AEs) | To evaluate the safety and tolerability of donepezil for up to 20 weeks in mild to moderate Alzheimer's disease( AD) patients. | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monitor and record the number of patients withdrew from trial for adverse events | To evaluate the safety and tolerability of donepezil for up to 20 weeks in mild to moderate AD patients by recording incidence of withdraw in each type adverse events. | 20 weeks | 
| Change from baseline to 20 weeks in MMSE scores | To evaluate the efficacy of Donepezil with titration on cognitive function measured the change scores of mini-mental state examination (MMSE) at 4 weeks and 20 weeks in mild to moderate AD patients. | Baseline, 4, 20 weeks | 
| Change from baseline to 20 weeks in ADL scores | To evaluate the efficacy of Donepezil with titration for on activities of daily living measured the scores of Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) inventory at 4 weeks and 20 weeks in mild to moderate AD patients. | Baseline, 4, 20 weeks | 
| Correlation analysis between Apo-E genotyping and adverse events of donepezil | To detect and analyze the Apo-E genotyping using the blood sample obtained in Visting 2 at the end of week 4. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AD, Donepezil, Safety