Official Title: “A Multi-Center Study for the Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease”

This study attempts to differentiate the clinical responses of Choline Acetyltransferase and Apolipoprotein Epsilon gene polymorphism to donepezil in Alzheimer's Disease patients.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

• Drug: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• CERAD-K(N), CIBIS/CIBIC-plus, NPI
  • Time Frame: 0, 12, 26 weeks
    Safety Issue?: Yes

Inclusion criteria:

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

Exclusion criteria:

• 1. Patients who have delusion 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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 60 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eisai Korea Inc.

Overall Clinical Trial Officials and Contacts

Jihee Mun Study Director Eisai Korea Inc.  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00381381

Study ID Number: EKI-6-00457

ClinicalTrials.gov Identifier: NCT00381381

Health Authority: Korea: Food and Drug Administration