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

Phase 4

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Donepezil

• Registration Number: NCT00381381
• Lead Sponsor: Eisai Korea Inc.

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

Not available

Study Timeline

• Study Start: 2006-05-31
• Study First Submitted: 2006-09-25
• Study First Submitted QC: 2006-09-25
• Study First Posted: 2006-09-27
• Primary Completion: 2008-08-31
• Study Completion: 2008-12-31
• Status Verified: 2010-07
• Results First Submitted: 2010-08-03
• Results First Submitted QC: 2012-06-20
• Results First Posted: 2012-07-27
• Last Update Submitted: 2021-12-10
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Donepezil	-

Primary Outcome Measures

Name	Time	Method
CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease)	26 weeks	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	26 weeks	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

Name	Time	Method
Neuropsychiatry Inventory (NPI)	26 weeks	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	26 weeks	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.

Trial Locations

Locations (15)

Seoul National University Bundang Hospital; 🇰🇷 Bundang, Korea, Republic of

Jeonju City Welfare Hospital; 🇰🇷 Jeonju, Korea, Republic of

Hallym University Medical Center; 🇰🇷 Changwon, Korea, Republic of

Gyeonggi Province Geriatric Hospital; 🇰🇷 Gyeonggi, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Uijeongbu St. Mary's Hospital; 🇰🇷 Gyeonggi, Korea, Republic of

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of

Inje University Pusan Paik Hospital; 🇰🇷 Pusan, Korea, Republic of

Kunkuk University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangwon National University Hospital; 🇰🇷 Chuncheon, Korea, Republic of

Kunkuk University Chungju Hospital; 🇰🇷 Chungju, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Gyeongsang National University Hospital; 🇰🇷 Jinju, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Chungnam National University Hospital; 🇰🇷 Daejeon, Korea, Republic of