The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

NCT ID: NCT00381381

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2008-12-31

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.

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Donepezil

Intervention Type: DRUG

2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.

Interventions

Donepezil

2.5mg once daily for the first 7 days, 5mg once daily for the next 3 weeks, after then the dose can be increased 10mg once daily under the investigator's decision.

Intervention Type: DRUG

Other Intervention Names

Aricept

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Korea Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jihee Mun

Role: STUDY_DIRECTOR

Eisai Korea Inc.

Locations

Seoul National University Bundang Hospital

Bundang, , South Korea

Hallym University Medical Center

Changwon, , South Korea

Kangwon National University Hospital

Chuncheon, , South Korea

Kunkuk University Chungju Hospital

Chungju, , South Korea

Kyungpook National University Hospital

Daegu, , South Korea

Chungnam National University Hospital

Daejeon, , South Korea

Gyeonggi Province Geriatric Hospital

Gyeonggi-do, , South Korea

Uijeongbu St. Mary's Hospital

Gyeonggi-do, , South Korea

Jeju National University Hospital

Jeju City, , South Korea

Jeonju City Welfare Hospital

Jeonju, , South Korea

Gyeongsang National University Hospital

Jinju, , South Korea

Inje University Pusan Paik Hospital

Pusan, , South Korea

Kunkuk University Hospital

Seoul, , South Korea

Seoul National University Hospital

Seoul, , South Korea

Seoul St. Mary's Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

EKI-6-004

Identifier Type: -

Identifier Source: org_study_id