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

Eisai

Status and phase: Completed; Phase 4

Conditions: Alzheimer's Disease

Treatments: Drug: Donepezil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00381381

EKI-6-004

Details and patient eligibility

About

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

Enrollment: 199 patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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199 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Donepezil