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

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.

Inclusion criteria

• Patients between 50 and 85 years of age.
• Patients newly diagnosed as probable AD based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and National Institute of Neurologic and Communicative Disorders and Stroke-AD and Related Disorders Association (NINCDS-ADRDA) criteria; Mild to moderate AD with Mini-Mental State Examination (MMSE) 10-24, modified Hachinski ischaemic scale (MHIS)≤4, Activity of daily life scale (ADL)≥23, and Hamilton Depression Scale (HAMD) <7.
• MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2 within 6 months prior to the screening).
• 5mg daily of Donepezil for at least four weeks before the screening.
• Patient with exclusive caregiver.
• Patient should be ambulatory or ambulatory aided by a walker or cane.
• With good eyesight and hearing, can cooperate with the examination and treatment.

Exclusion criteria

• Patients with vascular dementia, other types of dementia or with other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc.).
• Patients 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<50 beats/minute [bpm]).
• Epilepsy or head trauma resulting in unconsciousness that occurred in the two years prior to the screening.
• Patients with hematologic diseases (such as anemia, granulocytes, leukemia, etc.), tumor, neoplasms within 2 years prior to the screening.
• Patients with a history of alcohol dependence and drug abuse.
• Patients with known hypersensitivity to medicines or foods;
• Patients taking anticholinergic agents or antihistaminic agents;
• Patients who had been hospitalized continuously for more than 3 months before the screening.