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Sponsors and Collaborators: |
Eisai Medical Research Inc. Eisai Limited |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00478205 |
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with moderate to severe Alzheimer's disease.
Condition | Intervention | Phase |
---|---|---|
Alzheimer's Disease |
Drug: Aricept (donepezil SR 23 mg) Drug: Aricept (donepezil IR 10 mg) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Double-Blind, Parallel-Group Comparison of 23 mg Donepezil Sustained Release (SR) to 10 mg Donepezil Immediate Release (IR) in Patients With Moderate to Severe Alzheimer's Disease |
Estimated Enrollment: | 1200 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Aricept (donepezil SR 23 mg)
Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 23 mg donepezil SR concurrently with placebo identical in appearance to the 10 mg donepezil IR formulation. |
2: Experimental |
Drug: Aricept (donepezil IR 10 mg)
Patients will receive study medication orally, once daily, for 24 weeks according to a double-dummy design: 10 mg donepezil IR concurrently with placebo identical in appearance to the 23 mg donepezil SR formulation. |
This study consists of a double-blind, double-dummy, parallel-group comparison of 23 mg donepezil SR with the currently marketed donepezil formulation (10 mg donepezil IR) in patients with moderate to severe Alzheimer's disease. Patients must have been taking 10 mg IR (or a bioequivalent generic) for at least 3 months prior to Screening. The study will consist of 24 weeks of daily administration of study medication, with clinic visits at Screening, Baseline, 3 weeks (safety only), 6 weeks, 12 weeks, 18 weeks and 24 weeks or early termination. Patients will receive either 10 mg donepezil IR in combination with the placebo corresponding to 23 mg donepezil SR, or 23 mg donepezil SR in combination with the placebo corresponding to 10 mg donepezil IR. A total of approximately 1600 patients will be enrolled to obtain complete data from approximately 1200 completed patients (Revised per Amendment 02).
During the Baseline visit, patients will be randomized in a 2:1 ratio (23 mg donepezil SR to 10 mg donepezil IR). The study will be performed at approximately 200 global sites (Asia, Oceania, Europe, India, Israel, North America, South Africa, and South America) (Revised per Amendments 01 and 02).
An Independent Data Monitoring Committee (IDMC) will be established to review safety aspects of the study and to evaluate the results of a planned interim analysis. Patients who complete the study may be eligible to undergo evaluation for enrollment into the open-label extension study, E2020-G000-328.
Ages Eligible for Study: | 45 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria for Patients:
Inclusion Criteria for Caregivers:
The designated caregiver must be sufficiently familiar with the patient (as determined by the investigator) to provide accurate data. The caregiver must have regular contact with the patient (i.e., an average of 10 or more hours per week), must be able to observe for possible adverse events, and must be able to accompany the patient to all visits.
Exclusion Criteria for Patients:
Patients with neurological disorders that affect cognition or the ability to assess cognition but are distinguishable from Alzheimer's disease.
These include, but are not limited to, Parkinson's disease, multi-infarct dementia, and dementia due to cerebrovascular disease.
Exclusion Criteria for Caregivers:
United States, North Carolina | |
MedTrials, Inc. | |
Hickory, North Carolina, United States, 28601 |
Study Director: | Jane Yardley, Ph.D | Eisai Limted |
Responsible Party: | Eisai Limited ( Jane Yardley, Ph.D ) |
Study ID Numbers: | E2020-G000-326 |
Study First Received: | May 22, 2007 |
Last Updated: | February 24, 2009 |
ClinicalTrials.gov Identifier: | NCT00478205 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 |