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

NCT00381381 | Completed Phase 4 Results

• 1 other identifier: EKI-6-004
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 15

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Neuropsychiatry Inventory (NPI)

  26 weeks

• GDS-K (Geriatric Depression Scale-Korean) Score After Treatment

  26 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Donepezil

Interventions

Donepezil DRUG

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.

Also known as: Aricept

1

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Korea Inc.: lead

Study Sites (15)

Seoul National University Bundang Hospital

Bundang, South Korea

Location

Hallym University Medical Center

Changwon, South Korea

Location

Kangwon National University Hospital

Chuncheon, South Korea

Location

Kunkuk University Chungju Hospital

Chungju, South Korea

Location

Kyungpook National University Hospital

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Gyeonggi Province Geriatric Hospital

Gyeonggi-do, South Korea

Location

Uijeongbu St. Mary's Hospital

Gyeonggi-do, South Korea

Location

Jeju National University Hospital

Jeju City, South Korea

Location

Jeonju City Welfare Hospital

Jeonju, South Korea

Location

Gyeongsang National University Hospital

Jinju, South Korea

Location

Inje University Pusan Paik Hospital

Pusan, South Korea

Location

Kunkuk University Hospital

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Jihee Mun, Pharmacist, Medical team manager
• Organization: Eisai Korea Inc.

jihee_mun@eisaikorea.com

+82-2-3451-5531

Study Officials

• Jihee Mun

  Eisai Korea Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2006
• First Posted: September 27, 2006
• Study Start: May 31, 2006
• Primary Completion: August 31, 2008
• Study Completion: December 31, 2008
• Last Updated: January 4, 2022
• Results First Posted: July 27, 2012

Record last verified: 2010-07

Locations

KR (15)