Clinical trial NCT00381381: The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
Official title: A Multi-center Study for the Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-27
Enrollment: 199
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 criteria:

1. Age: 60 - 90 years old.
2. CDR: 0.5 - 2.0.
3. Patients who do not have severe depressive symptoms that affect cognition on depression scale of CERAD-K(C), GDS-K: 19 and below.
4. Modified Hachinski Ischemic Score (Rosen, et. al., 1979): 3 and below.
5. NINCDS-ADRDA criteria: Probable AD.

Exclusion criteria:

1. Patients who have delusions and other conscious dysfunction.
2. Patients who have neurologic diseases such as Parkinson's disease, stroke, tumor, normal pressure hydrocephalus, etc., on history and neurologic examination.
3. Patients who have history of infectious and inflammatory brain disease owing to virus, fungus and syphilis.
4. Patients with severe cerebrovascular pathology.
5. Patients who have present history of major psychological diseases such as depression and mania according to DSM-IV criteria.
6. Patients who have history of alcoholism or drug addiction.
7. Patients who have severe depressive symptoms that affect cognition on depression scale of CERAD-K.

Primary outcomes:
measure: CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)
timeFrame: 26 weeks
measure: CERAD-K
timeFrame: 26 weeks
Secondary outcomes:
measure: Neuropsychiatry Inventory (NPI)
timeFrame: 26 weeks
measure: GDS-K (Geriatric Depression Scale-Korean) Score After Treatment
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Bundang
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Changwon
country: Korea, Republic of
facility: Hallym University Medical Center
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Chungju
country: Korea, Republic of
facility: Kunkuk University Chungju Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gyeonggi
country: Korea, Republic of
facility: Gyeonggi Province Geriatric Hospital
city: Gyeonggi
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
city: Jeju
country: Korea, Republic of
facility: Jeju National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonju City Welfare Hospital
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Kunkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Eisai Korea Inc.
name: Jihee Mun
role: STUDY_DIRECTOR
References: