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Sponsored by: |
Eisai Korea Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00381381 |
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 |
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.
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Ages Eligible for Study: | 60 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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 |
Health Authority: | Korea: Food and Drug Administration |
Choline Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nootropic Agents Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Tauopathies Central Nervous System Agents Pharmacologic Actions |