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

Alzheimer's Disease Clinical Trial

— STDMMAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787746
• Other study ID #: STD-CHINA-001
• Status: Completed
• Phase: Phase 4
• Start date: April 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2019
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

1. 50 = years of age < 85years.

2. 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.

3. MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions=2).

4. 5mg daily of Donepezil for at least four weeks before enrollment.

5. Patient with exclusive caregiver.

6. Move freely with or without walking aid.

7. With good eyesight and hearing, can cooperate with the examination and treatment.

8. Patient and caregiver who signed the written informed consent form for the terms of personal and medical information.

Exclusion Criteria:

1. With Vascular dementia or other types of dementia. Accompanied by other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc).

2. 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).

3. Epilepsy or head trauma resulted in unconsciousness once occured in the past two years.

4. Blood diseases (such as anemia, granulocytes, leukemia, etc) or tumor 5. With Hematologic Disease or neoplasms within past 2 years.

5. Has a history of alcohol dependence and drug abuse.

6. With known hypersensitivity to medicines or foods.

7. Taking anticholinergic agents or antihistaminic agents.

8. Patients who had been hospitalized continuously for more than 3 months before screening.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Donepezil
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.

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Beijing Friendship Hospital	Eisai China Inc., Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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