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

This study has been completed.

First Received: September 25, 2006 Last Updated: January 7, 2009 History of Changes

Sponsor:	Eisai Korea Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00381381

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Choline E 2020 Donepezil

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

CERAD-K(N), CIBIS/CIBIC-plus, NPI [ Time Frame: 0, 12, 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	145
Study Start Date:	August 2006
Study Completion Date:	December 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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.

Eligibility

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

Criteria

Inclusion criteria:

Age: 60 - 90 years old.
Education: over six years.
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.

Contacts and Locations

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

Locations

Korea, Republic of
Kangwon National University Hospital
Chuncheon, 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 Korea Inc. ( Jihee Mun )
Study ID Numbers:	EKI-6-004
Study First Received:	September 25, 2006
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00381381 History of Changes
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases

Neurodegenerative Diseases
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Donepezil
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 30, 2009