Status:
COMPLETED
The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
Lead Sponsor:
Eisai Korea Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
60-90 years
Phase:
PHASE4
Brief Summary
This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age: 60 - 90 years old.
- CDR: 0.5 - 2.0.
- Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.
- Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.
- NINCDS-ADRDA criteria: Probable AD.
- Exclusion criteria:
- Patients who have delusions and other conscious dysfunction.
- Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.
- Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.
- Patients with severe cerebrovascular pathology.
- Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.
- Patients who have history of alcoholism or drug addiction.
- Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.
Exclusion
Key Trial Info
Start Date :
May 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2008
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT00381381
Start Date
May 31 2006
End Date
December 31 2008
Last Update
January 4 2022
Active Locations (15)
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1
Seoul National University Bundang Hospital
Bundang, South Korea
2
Hallym University Medical Center
Changwon, South Korea
3
Kangwon National University Hospital
Chuncheon, South Korea
4
Kunkuk University Chungju Hospital
Chungju, South Korea