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

Tracking Information

First Received Date ^ICMJE

September 25, 2006

Last Updated Date

January 7, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

CERAD-K(N), CIBIS/CIBIC-plus, NPI [ Time Frame: 0, 12, 26 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

CERAD-K(N), CIBIS/CIBIC-plus, NPI

Change History

Complete list of historical versions of study NCT00381381 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: Donepezil

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

145

Completion Date

December 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion criteria:

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

Exclusion criteria:

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

Gender

Both

Ages

60 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00381381

Responsible Party

Jihee Mun, Eisai Korea Inc.

Study ID Numbers ^ICMJE

EKI-6-004

Study Sponsor ^ICMJE

Eisai Korea Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Jihee Mun

Eisai Korea Inc.

Information Provided By

Eisai Inc.

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP