Back to resultsClinical Trial of Donepezil Between the Naive Group and the Switching Group
Primary Purpose
Alzheimer's Disease, Dementia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
donepezil
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring naive group, switching group, treatment response, Efficacy, Adverse event
Eligibility Criteria
Inclusion Criteria:
- A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
- Korean version Mini-Mental State Examination scores between 10 and 26
- History of cognitive decline that had been gradual in onset and progressive over at least 6 months
- A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Exclusion Criteria:
- they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
- Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
- Cerebral injuries induced by trauma, hypoxia, and/or ischemia
- Clinically active cerebrovascular disease; History of seizure disorder
- Other physical conditions that required acute treatment.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
switching group
naive group
Arm Description
switching patients with Alzheimer's disease(AD) from galantamine or rivastigmine to donepezil because they were not responding adequately
naive patients with AD who initiated therapy with donepezil
Outcomes
Primary Outcome Measures
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
Secondary Outcome Measures
Seoul Activities of Daily Living (S-ADL)
Seoul-Instrumental Activities of Daily Living (S-IADL)
Korean Neuropsychiatric Inventory (K-NPI)
Full Information
NCT ID
NCT01023425
First Posted
November 30, 2009
Last Updated
January 4, 2016
Sponsor
Samsung Medical Center
Collaborators
Eisai Korea Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01023425
Brief Title
Clinical Trial of Donepezil Between the Naive Group and the Switching Group
Official Title
Comparative Assessment of Clinical Efficacy of Donepezil Between the Naive Group and the Switching Group
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Eisai Korea Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To compare the clinical efficacy of donepezil between the naive group and the switching group.
Detailed Description
The purposes of this study are:
to compare the efficacy between switching patients with Alzheimer's disease (AD) from galantamine or rivastigmine to donepezil because they were not responding adequately, and naive patients with AD who initiated therapy with donepezil
to help to clinicians in choosing the best treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia
Keywords
naive group, switching group, treatment response, Efficacy, Adverse event
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
switching group
Arm Type
Experimental
Arm Description
switching patients with Alzheimer's disease(AD) from galantamine or rivastigmine to donepezil because they were not responding adequately
Arm Title
naive group
Arm Type
Experimental
Arm Description
naive patients with AD who initiated therapy with donepezil
Intervention Type
Drug
Intervention Name(s)
donepezil
Other Intervention Name(s)
donepezil-aricept
Intervention Description
from 5mg to 10mg, once a day, 12 months
Primary Outcome Measure Information:
Title
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
Time Frame
13 weeks, 26 weeks, 39 weeks, 52 weeks
Secondary Outcome Measure Information:
Title
Seoul Activities of Daily Living (S-ADL)
Time Frame
13 weeks, 26 weeks, 39 weeks, 52 weeks
Title
Seoul-Instrumental Activities of Daily Living (S-IADL)
Time Frame
13 weeks, 26 weeks, 39 weeks, 52 weeks
Title
Korean Neuropsychiatric Inventory (K-NPI)
Time Frame
13 weeks, 26 weeks, 39 weeks, 52 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A diagnosis of probable AD according to the criteria of the NINCDS-ADRDA
Korean version Mini-Mental State Examination scores between 10 and 26
History of cognitive decline that had been gradual in onset and progressive over at least 6 months
A caregiver who could assist the patient with medication, attend the assessment and provide information about the patient.
Exclusion Criteria:
they had evidence of any neurodegenerative diseases other than AD (i.e. Parkinson's disease, Huntington's disease)
Psychiatric disorder or severe behavioral disturbances that required psychotropic medications
Cerebral injuries induced by trauma, hypoxia, and/or ischemia
Clinically active cerebrovascular disease; History of seizure disorder
Other physical conditions that required acute treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doh Kwan Kim, PhD, M.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of Donepezil Between the Naive Group and the Switching Group
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