Clinical trial NCT02787746: Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease
Official title: Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: AD
Donepezil
Safety
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Eisai China Inc.
name: Xuanwu Hospital, Beijing
First posted: 2016-06-01
Enrollment: 241
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: multi-center, single-arm, open labeling clinical trial
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Patients between 50 and 85 years of age.
2. 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.
3. 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).
4. 5mg daily of Donepezil for at least four weeks before the screening.
5. Patient with exclusive caregiver.
6. Patient should be ambulatory or ambulatory aided by a walker or cane.
7. With good eyesight and hearing, can cooperate with the examination and treatment.

Exclusion Criteria:

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

Primary outcomes:
measure: Number of Patients With Adverse Events (AEs)
timeFrame: 20 weeks
Secondary outcomes:
measure: Number of Patients Who Withdrew From the Trial Due to Adverse Events.
timeFrame: 20 weeks
measure: Changes in Mini-Mental State Examination Scores From Baseline
timeFrame: Baseline, 4, 20 weeks
measure: Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline
timeFrame: Baseline, 4, 20 weeks
measure: Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil
timeFrame: 20 weeks
measure: APOE Genotype
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Dept of Neurology, Beijing Friendship Hospital, Capital Medical University
name: Cuibai Wei, MD,PhD
role: STUDY_DIRECTOR
References:
citation: Jia J, Wei C, Chen W, Jia L, Zhou A, Wang F, Tang Y, Xu L. Safety and Efficacy of Donepezil 10 mg/day in Patients with Mild to Moderate Alzheimer's Disease. J Alzheimers Dis. 2020;74(1):199-211. doi: 10.3233/JAD-190940.