At a glance
ClinicalIndex Comparison Record- ✓Age 50–85 years
- ✓Probable Alzheimer's disease diagnosed by DSM-IV-TR and NINCDS-ADRDA criteria
- ✓Mild to moderate dementia (MMSE 10–24)
- ✓Modified Hachinski ischaemic scale ≤4 (low vascular burden)
- ✕Vascular dementia, other dementia types, or other psychiatric/neurological disorders (delirium, depression, Parkinson's disease)
- ✕Type 1 diabetes, obstructive lung disease, asthma, vitamin B12/folic acid deficiency, thyroid dysfunction
- ✕Severe hepatic or renal dysfunction
- ✕Severe cardiac insufficiency (congestive heart failure, myocardial infarction, sick sinus syndrome, II–III degree atrioventricular block, or heart rate <50 bpm)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China
In Brief
A Phase 4 clinical trial evaluating Donepezil for Alzheimer's Disease. Completed, enrolled 241 participants across 1 site.
Detailed Summary
This study will evaluate the safety and Efficacy of donepezil in treatment of AD patients in China.
Study Details
Timeline
Interventions
Eligible patients were 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 dose could be reduce to 5mg/d for 4 weeks and then increase back to 10mg/d. Patients who could not endure the 10mg/d titration the 2nd time and were put back to 5mg/d or discontinuance of Aricept® should be considered as withdrawal from the study. There were a visit (visit 1) at week 0, the end of week 4 (visit 2) and the end of week 20 (visit 3), respectively.