Clinical Trial of Donepezil Between the Naive Group and the Switching Group
Comparative Assessment of Clinical Efficacy of Donepezil Between the Naive Group and the Switching Group
1 other identifier
interventional
72
1 country
1
Brief Summary
To compare the clinical efficacy of donepezil between the naive group and the switching group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedJanuary 6, 2016
January 1, 2016
1.2 years
November 30, 2009
January 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale-Cognitive, Korean version (ADAS-Cog-K)
13 weeks, 26 weeks, 39 weeks, 52 weeks
Secondary Outcomes (3)
Seoul Activities of Daily Living (S-ADL)
13 weeks, 26 weeks, 39 weeks, 52 weeks
Seoul-Instrumental Activities of Daily Living (S-IADL)
13 weeks, 26 weeks, 39 weeks, 52 weeks
Korean Neuropsychiatric Inventory (K-NPI)
13 weeks, 26 weeks, 39 weeks, 52 weeks
Study Arms (2)
switching group
EXPERIMENTALswitching patients with Alzheimer's disease(AD) from galantamine or rivastigmine to donepezil because they were not responding adequately
naive group
EXPERIMENTALnaive patients with AD who initiated therapy with donepezil
Interventions
from 5mg to 10mg, once a day, 12 months
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Eisai Korea Inc.collaborator
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Doh Kwan Kim, PhD, M.D.
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 30, 2009
First Posted
December 2, 2009
Study Start
February 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
January 6, 2016
Record last verified: 2016-01