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

March 4, 2019 updated by: Jianping Jia, Beijing Friendship Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

241

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Friendship Hospital, Capital Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: donepezil
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
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 Names:
  • Aricept

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
20 weeks
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.
Baseline, 4, 20 weeks
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.
Baseline, 4, 20 weeks
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Collaborators

Xuanwu Hospital, Beijing
Eisai China Inc.

Investigators

  • Study Director: Cuibai Wei, MD,PhD, Dept of Neurology, Beijing Friendship Hospital, Capital Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimate)

June 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STD-CHINA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

No data will be share.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Donepezil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe