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

Plain-language summary

This study investigates how choline acetyltransferase and Apolipoprotein E gene polymorphisms (genetic variations) relate to the response to the drug Donepezil in Alzheimer's Disease. It included patients aged 60-90 with probable Alzheimer's. It was a Phase 4 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 4

Status

Completed

Sponsor

Eisai Korea Inc.

Intervention

Donepezil

Start date

5/31/2006

Estimated completion

12/31/2008

Countries

South Korea

Related genes

Locations

• Bundang, South Korea
• Changwon, South Korea
• Chuncheon, South Korea
• Chungju, South Korea
• Daegu, South Korea
• Daejeon, South Korea
• Gyeonggi-do, South Korea
• Gyeonggi-do, South Korea
• Jeju City, South Korea
• Jeonju, South Korea
• Jinju, South Korea
• Pusan, South Korea
• Seoul, South Korea
• Seoul, South Korea
• Seoul, South Korea

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.