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Sponsors and Collaborators: |
Eisai Inc. Pfizer |
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Information provided by: | Eisai Inc. |
ClinicalTrials.gov Identifier: | NCT00711204 |
A 12-week, multicenter, randomized, double-blind, placebo-controlled phase IV study. Approximately 200 subjects will be enrolled, half will receive active drug (donepezil hydrochloride) and half will receive matching placebo at approximately 50 research sites within the US, the European Union, South Africa and Australia. Eligible subjects will reside at home, in an assisted living facility, or nursing homes age and will be 50 years or older, with a diagnosis of Alzheimer's disease in the severe stage. All subjects must start with 5mg a day (one 5 mg tablet of donepezil HCL or matching placebo). Dose will be increased to 10 mg a day (two tablets of 5 mg donepezil HCL or matching placebo) after 4 weeks. Dose may be decreased based on side effects. The primary efficacy measure will be the Cornell Scale for Depression in Dementia (CSDD). Secondary measures will include Functional Assessment Staging (FAST), Mini-Mental State Examination (MMSE), NPI-10 (Neuropsychiatric Inventory), DEMQOL Proxy ( Quality of Life). Blood levels of cytokines and safety will also be assessed.
Condition | Intervention | Phase |
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Severe Alzheimer's Disease |
Drug: Donepezil Hydrochloride (Aricept) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Impact Of Donepezil Hydrochloride (Aricept) On Behavioral And Psychological Symptoms In Patients With Severe Alzheimer's Disease |
Estimated Enrollment: | 200 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator |
Drug: Donepezil Hydrochloride (Aricept)
5mg (or 10mg) tablet, once daily, with a full glass of water.
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2: Active Comparator |
Drug: Donepezil Hydrochloride (Aricept)
5mg (or 10mg) tablet, once daily, with a full glass of water.
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer Inc. ( Daphne Aime ) |
Study ID Numbers: | E2020-A001-417 |
Study First Received: | January 21, 2008 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00711204 History of Changes |
Health Authority: | United States: Institutional Review Board |
Severe Alzheimer's Disease |
Nootropic Agents Neurotransmitter Agents Alzheimer Disease Central Nervous System Diseases Cholinergic Agents Brain Diseases Neurodegenerative Diseases Cognition Disorders |
Cholinesterase Inhibitors Methamphetamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Amphetamine 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 |