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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 9, 2004 | ||||||||
| Last Updated Date | March 1, 2007 | ||||||||
| Start Date ICMJE | January 2001 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
Assessments of global and cognitive function of Severe AD patients | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00096473 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer’s Disease | ||||||||
| Official Title ICMJE | A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period | ||||||||
| Brief Summary | Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer’s disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer’s disease. Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person’s memory to work better. |
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| Detailed Description | |||||||||
| Study Phase | Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Donepezil hydrochloride | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 350 | ||||||||
| Completion Date | June 2005 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States, Australia, Canada, Ireland, United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00096473 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | E2020-A001-315 | ||||||||
| Study Sponsor ICMJE | Eisai Inc. | ||||||||
| Collaborators ICMJE | Pfizer | ||||||||
| Investigators ICMJE |
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| Information Provided By | Eisai Inc. | ||||||||
| Verification Date | March 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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