Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease (STDMMAD)
|ClinicalTrials.gov Identifier: NCT02787746|
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : March 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: Donepezil||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||241 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||multi-center, single-arm, open labeling clinical trial|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China|
|Actual Study Start Date :||April 2016|
|Actual Primary Completion Date :||January 2019|
|Actual Study Completion Date :||March 2019|
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.
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.
Other Name: Aricept
- Monitoring and recording the count and incidence of adverse events (AEs) [ Time Frame: 20 weeks ]To evaluate the safety and tolerability of donepezil for up to 20 weeks in mild to moderate Alzheimer's disease( AD) patients.
- Monitor and record the number of patients withdrew from trial for adverse events [ Time Frame: 20 weeks ]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.
- Change from baseline to 20 weeks in MMSE scores [ Time Frame: Baseline, 4, 20 weeks ]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.
- Change from baseline to 20 weeks in ADL scores [ Time Frame: Baseline, 4, 20 weeks ]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.
- Correlation analysis between Apo-E genotyping and adverse events of donepezil [ Time Frame: 4 weeks ]To detect and analyze the Apo-E genotyping using the blood sample obtained in Visting 2 at the end of week 4.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787746
|Beijing Friendship Hospital, Capital Medical University|
|Beijing, Beijing, China|
|Study Director:||Cuibai Wei, MD,PhD||Dept of Neurology, Beijing Friendship Hospital, Capital Medical University|