Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 331 for:    DONEPEZIL
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02787746
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
Eisai China Inc.
Xuanwu Hospital, Beijing
Information provided by (Responsible Party):
Jianping Jia, Beijing Friendship Hospital

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Donepezil Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 241 participants
Intervention Model: Single Group Assignment
Intervention Model Description: multi-center, single-arm, open labeling clinical trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Donepezil in Mild to Moderate Alzheimer's Disease: A Multi-center Single-arm Study in China
Actual Study Start Date : April 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : March 2019


Arm Intervention/treatment
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 Name: Aricept




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787746


Locations
Layout table for location information
China, Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, China
Sponsors and Collaborators
Beijing Friendship Hospital
Eisai China Inc.
Xuanwu Hospital, Beijing
Investigators
Layout table for investigator information
Study Director: Cuibai Wei, MD,PhD Dept of Neurology, Beijing Friendship Hospital, Capital Medical University

Layout table for additonal information
Responsible Party: Jianping Jia, Director of Neurology Department, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT02787746     History of Changes
Other Study ID Numbers: STD-CHINA-001
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No data will be share.
Keywords provided by Jianping Jia, Beijing Friendship Hospital:
AD
Donepezil
Safety
Additional relevant MeSH terms:
Layout table for MeSH terms
Donepezil
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents