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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier:
NCT00381381
First received: September 25, 2006
Last updated: August 23, 2012
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: Donepezil
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center Study for the Clinical Response of Choline Acetyltransferase and Apolipoprotein Epsilon Gene Polymorphisms to Donepezil in Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • CERAD-K (the Korean Version of the Consortium to Establish a Registry for Alzheimer's Disease) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 199
Study Start Date: May 2006
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.
Other Name: Aricept

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381381

Locations
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
Uijeongbu St. Mary's Hospital
Gyeonggi, Korea, Republic of
Gyeonggi Province Geriatric 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
Seoul National University Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of
Kunkuk University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Eisai Korea Inc.
Investigators
Study Director: Jihee Mun Eisai Korea Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Korea Inc. )
ClinicalTrials.gov Identifier: NCT00381381     History of Changes
Other Study ID Numbers: EKI-6-004
Study First Received: September 25, 2006
Results First Received: August 3, 2010
Last Updated: August 23, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Eisai Inc.:
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014