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| Sponsors and Collaborators: |
Eisai Medical Research Inc. Eisai Limited |
|---|---|
| Information provided by: | Eisai Medical Research Inc. |
| ClinicalTrials.gov Identifier: | NCT00566501 |
Purpose
The purpose of this study is to evaluate the safety and efficacy of long-term administration of 23 mg donepezil sustained release (SR) in patients with moderate to severe Alzheimer's disease. Patients who complete study E2020-G000-326 with no ongoing serious adverse events (SAEs) and no serious adverse drug reactions will be eligible to enter the open-label extension study.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: Donepezil hydrochloride SR |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Open-Label Extension Study of 23 mg Donepezil SR in Patients With Moderate to Severe Alzheimer's Disease |
| Estimated Enrollment: | 1200 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | August 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Donepezil hydrochloride SR
Patients will receive 23 mg donepezil SR orally, once daily for 12 months.
|
Eligibility| Ages Eligible for Study: | 45 Years to 91 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria for Patients:
Exclusion Criteria for Patients:
1. Caregivers who are unwilling or unable to give informed consent or otherwise to fulfill the requirements of the study.
2. Any condition that would make the caregiver, in the opinion of the investigator, unsuitable for the study.
Contacts and Locations| United States, California | |
| Apex Research Institute | |
| Santa Ana, California, United States, 92705 | |
| Study Director: | Jane Yardley, Ph.D | Eisai Limited |
More Information
| Responsible Party: | Eisai Limited ( Jane Yardley, Ph.D, Study Director ) |
| Study ID Numbers: | E2020-G000-328 |
| Study First Received: | November 29, 2007 |
| Last Updated: | April 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00566501 History of Changes |
| Health Authority: | United States: Food and Drug Administration; European Union: European Medicines Agency |
|
Moderate-to-severe Alzheimer's Disease |
|
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 |