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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Donepezil
Sponsored by
Eisai Korea Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's disease

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Seoul National University Bundang Hospital
  • Hallym University Medical Center
  • Kangwon National University Hospital
  • Kunkuk University Chungju Hospital
  • Kyungpook National University Hospital
  • Chungnam National University Hospital
  • Gyeonggi Province Geriatric Hospital
  • Uijeongbu St. Mary's Hospital
  • Jeju National University Hospital
  • Jeonju City Welfare Hospital
  • Gyeongsang National University Hospital
  • Inje University Pusan Paik Hospital
  • Kunkuk University Hospital
  • Seoul National University Hospital
  • Seoul St. Mary's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)
CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).
CERAD-K
CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.

Secondary Outcome Measures

Neuropsychiatry Inventory (NPI)
NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.
GDS-K (Geriatric Depression Scale-Korean) Score After Treatment
GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.

Full Information

First Posted
September 25, 2006
Last Updated
December 10, 2021
Sponsor
Eisai Korea Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00381381
Brief Title
The Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
Official Title
A Multi-center Study for the Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 31, 2006 (Actual)
Primary Completion Date
August 31, 2008 (Actual)
Study Completion Date
December 31, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Korea Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Donepezil
Other Intervention Name(s)
Aricept
Intervention Description
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.
Primary Outcome Measure Information:
Title
CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)
Description
CERAD-K includes: Verbal Fluency-number of kinds of animal patients listed per minute, ranges from 0, no maximum point fixed.Boston Naming Test is naming objects (0-15). Mini-Mental State Examination in the Korean version of CERAD Assessment Packet (0-30). Word List Memory (0-30). Construction Praxis is from 0-11. Word List Recall and Word List Recognition ranges from 0-10.Construction Recall (0-11).
Time Frame
26 weeks
Title
CERAD-K
Description
CERAD-K includes: Trail making test A and B is scored by the time spent to link randomly arranged numbers and alphabets in correct order. Except Trail making test A and B, higher score presents better condition.
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Neuropsychiatry Inventory (NPI)
Description
NPI score after treatment. NPI includes 12 sections which are Delusions, Hallucinations, Agitation, Depression, Anxiety, Euphoria, Apathy, Disinhibition, Irritability, Aberrant motor behavior, Night-time behaviors and Appetite and eating disorders. The score of each section ranges from 0 to 12, and higher score means higher severity and frequency of the neuropsychiatric disturbances.
Time Frame
26 weeks
Title
GDS-K (Geriatric Depression Scale-Korean) Score After Treatment
Description
GDS-K score after treatment. Geriatric Depression Scale is a basic screening measure for depression in older adults. It ranges from 0 to 30, and higher score represents more depressed.
Time Frame
26 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age: 60 - 90 years old. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jihee Mun
Organizational Affiliation
Eisai Korea Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Bundang
Country
Korea, Republic of
Facility Name
Hallym University Medical Center
City
Changwon
Country
Korea, Republic of
Facility Name
Kangwon National University Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Kunkuk University Chungju Hospital
City
Chungju
Country
Korea, Republic of
Facility Name
Kyungpook National University Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Gyeonggi Province Geriatric Hospital
City
Gyeonggi
Country
Korea, Republic of
Facility Name
Uijeongbu St. Mary's Hospital
City
Gyeonggi
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Facility Name
Jeonju City Welfare Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Gyeongsang National University Hospital
City
Jinju
Country
Korea, Republic of
Facility Name
Inje University Pusan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Kunkuk University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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