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

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Donepezil

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring AD, Donepezil, Safety

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

50 ≤ years of age < 85years.
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.
MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2).
5mg daily of Donepezil for at least four weeks before enrollment.
Patient with exclusive caregiver.
Move freely with or without walking aid.
With good eyesight and hearing, can cooperate with the examination and treatment.
Patient and caregiver who signed the written informed consent form for the terms of personal and medical information.

Exclusion Criteria:

With Vascular dementia or other types of dementia. Accompanied by other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc).
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).
Epilepsy or head trauma resulted in unconsciousness once occured in the past two years.
Blood diseases (such as anemia, granulocytes, leukemia, etc) or tumor 5. With Hematologic Disease or neoplasms within past 2 years.
Has a history of alcohol dependence and drug abuse.
With known hypersensitivity to medicines or foods.
Taking anticholinergic agents or antihistaminic agents.
Patients who had been hospitalized continuously for more than 3 months before screening.

Sites / Locations

Beijing Friendship Hospital, Capital Medical University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

donepezil

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

Full Information

NCT ID

NCT02787746

First Posted

March 6, 2016

Last Updated

March 4, 2019

Sponsor

Beijing Friendship Hospital

Collaborators

Eisai China Inc., Xuanwu Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT02787746

Brief Title

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

Acronym

STDMMAD

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

April 2016 (Actual)

Primary Completion Date

January 2019 (Actual)

Study Completion Date

March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Friendship Hospital

Collaborators

Eisai China Inc., Xuanwu Hospital, Beijing

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

AD, Donepezil, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

multi-center, single-arm, open labeling clinical trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

241 (Actual)

8. Arms, Groups, and Interventions

Arm Title

donepezil

Arm Type

Other

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Donepezil

Other Intervention Name(s)

Aricept

Intervention Description

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.

Primary Outcome Measure Information:

Title

Monitoring and recording the count and incidence of adverse events (AEs)

Description

To evaluate the safety and tolerability of donepezil for up to 20 weeks in mild to moderate Alzheimer's disease( AD) patients.

Time Frame

20 weeks

Secondary Outcome Measure Information:

Title

Monitor and record the number of patients withdrew from trial for adverse events

Description

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.

Time Frame

20 weeks

Title

Change from baseline to 20 weeks in MMSE scores

Description

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.

Time Frame

Baseline, 4, 20 weeks

Title

Change from baseline to 20 weeks in ADL scores

Description

Time Frame

Baseline, 4, 20 weeks

Title

Correlation analysis between Apo-E genotyping and adverse events of donepezil

Description

To detect and analyze the Apo-E genotyping using the blood sample obtained in Visting 2 at the end of week 4.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 50 ≤ years of age < 85years. 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. MRI image supports the diagnosis of AD (medial temporal lobe atrophy, Fazekas scale of white matter lesions≤2). 5mg daily of Donepezil for at least four weeks before enrollment. Patient with exclusive caregiver. Move freely with or without walking aid. With good eyesight and hearing, can cooperate with the examination and treatment. Patient and caregiver who signed the written informed consent form for the terms of personal and medical information. Exclusion Criteria: With Vascular dementia or other types of dementia. Accompanied by other psychiatric or neurological disorders (e.g. delirium, depression, Parkinson's disease, etc). 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). Epilepsy or head trauma resulted in unconsciousness once occured in the past two years. Blood diseases (such as anemia, granulocytes, leukemia, etc) or tumor 5. With Hematologic Disease or neoplasms within past 2 years. Has a history of alcohol dependence and drug abuse. With known hypersensitivity to medicines or foods. Taking anticholinergic agents or antihistaminic agents. Patients who had been hospitalized continuously for more than 3 months before screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cuibai Wei, MD,PhD

Organizational Affiliation

Dept of Neurology, Beijing Friendship Hospital, Capital Medical University

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Friendship Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

No data will be share.

Citations:

PubMed Identifier

31985467

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.

Results Reference

derived

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

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