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

NCT02787746 | Completed Phase 4 Results DMC

• 1 other identifier: STD-CHINA-001
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer's Disease

Keywords

AD; Donepezil; Safety

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events (AEs)

  Physical examinations such as vital signs and weight, clinical laboratory tests, and electrocardiograms (ECGs) during the 20 weeks.

  20 weeks

Secondary Outcomes (5)

• Number of Patients Who Withdrew From the Trial Due to Adverse Events.

  20 weeks

• Changes in Mini-Mental State Examination Scores From Baseline

  Baseline, 4, 20 weeks

• Changes in Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores From Baseline

  Baseline, 4, 20 weeks

• Correlation Between Apolipoprotein E.(APOE) Genotype and Incidence of Adverse Events of Donepezil

  20 weeks

• APOE Genotype

  4 weeks

Study Arms (1)

donepezil

OTHER

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.

Drug: Donepezil

Interventions

Donepezil DRUG

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.

Also known as: Aricept

donepezil

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Beijing Friendship Hospital: lead
• Eisai China Inc.: collaborator
• Xuanwu Hospital, Beijing: collaborator

Study Sites (1)

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 31985467 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jianping Jia
• Organization: Department of Neurology, Xuan Wu Hospital of Capital Medical University; Freindship Hospital of Capital Medical University

jjp@ccmu.edu.cn

+86 10 83188730

Study Officials

• Cuibai Wei, MD,PhD

  Dept of Neurology, Beijing Friendship Hospital, Capital Medical University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neurology Department

Model Details: multi-center, single-arm, open labeling clinical trial

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: June 1, 2016
• Study Start: April 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)