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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381381
• Other study ID #: EKI-6-004
• Status: Completed
• Phase: Phase 4
• Start date: May 31, 2006
• Est. completion date: December 31, 2008

Study information

• Verified date: July 2010
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: December 31, 2008
• Est. primary completion date: August 31, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Bundang
Korea, Republic of	Hallym University Medical Center	Changwon
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Kunkuk University Chungju Hospital	Chungju
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Gyeonggi Province Geriatric Hospital	Gyeonggi
Korea, Republic of	Uijeongbu St. Mary's Hospital	Gyeonggi
Korea, Republic of	Jeju National University Hospital	Jeju
Korea, Republic of	Jeonju City Welfare Hospital	Jeonju
Korea, Republic of	Gyeongsang National University Hospital	Jinju
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Kunkuk University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Korea Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	26 weeks
Primary	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.	26 weeks
Secondary	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.	26 weeks
Secondary	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.	26 weeks