Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease (STDMMAD)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|