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Sponsored by: |
Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00165659 |
To evaluate the dose-response efficacy of E2020 (5 mg/day and 10 mg/day) versus placebo and verify superiority of E2020 to placebo in patients with severe AD using CIBIC-plus* and SIB** as the primary efficacy measures. Safety of E2020 will also be evaluated.
(*for overall evalution of clinical symtoms) (**for cognitive function test)
Condition | Intervention | Phase |
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Alzheimer Disease |
Drug: DONEPEZIL HYDROCHLORIDE |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Study Start Date: | November 2002 |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
This contact is necessary to ensure accurate reporting of the patient's behavior and his/her ability to perform ADLs.
Exclusion Criteria:
Patients with dementia other than AD.
Study Director: | Itaru Arimoto | Eisai Co., Ltd - Development Clinical Research Dept., Clinical Research Center |
Study ID Numbers: | E2020-J081-231 |
Study First Received: | September 12, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00165659 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Nootropic Agents Neurotransmitter Agents Alzheimer Disease Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Cholinergic Agents |
Cognition Disorders Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Dementia Delirium |
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 |