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Sponsors and Collaborators: |
Eisai Inc. Pfizer |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00754052 |
The purpose of this study is to determine the efficacy and safety of donepezil hydrochloride (Aricept) in the treatment of the cognitive dysfunction shown by children with Down syndrome, aged 11 to 17.
Condition | Intervention | Phase |
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Down Syndrome, Cognitive Dysfunction |
Drug: Aricept (donepezil hydrochloride) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 10-Week, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 |
Estimated Enrollment: | 192 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Aricept (donepezil hydrochloride)
All subjects will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalation will occur at 2 weeks to a maximum of 5 mg/day (5 ml) donepezil. All doses will be administered orally.
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2: Active Comparator |
Drug: Aricept (donepezil hydrochloride)
All subjects will start with a dose of 2.5 mg/day (2.5 ml) donepezil ; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) donepezil. All doses will be administered orally.
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3: Placebo Comparator |
Drug: Placebo
All subjects will start with a dose of 2.5 mg/day (2.5 ml) placebo; dose escalations will occur every 2 weeks to a maximum of 10 mg/day (10 ml) placebo. All doses will be administered orally.
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The study will be conducted in approximately 75 sites in the US, India, Singapore, South Korea, Mexico and Chile and will include 210 subjects to be enrolled.
Ages Eligible for Study: | 11 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Road Runner Research | |
San Antonio, Texas, United States, 78258 | |
United States, Virginia | |
Neuroscience, Inc | |
Herndon, Virginia, United States, 20170 |
Study Director: | Thomas McRae, MD | Pfizer |
Responsible Party: | Eisai Inc. ( Eisai Medical Affairs ) |
Study ID Numbers: | E2020-A001-335, A2501061 |
Study First Received: | September 15, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00754052 |
Health Authority: | United States: Institutional Review Board; European Union: European Medicines Agency |
Pediatric Down syndrome Downs Cognitive Dysfunction of Down syndrome |
Chromosomal abnormalities Chromosome Disorders Cognition Disorders Mental Retardation Delirium, Dementia, Amnestic, Cognitive Disorders Genetic Diseases, Inborn Mental Disorders Donepezil |
Abnormalities, Multiple Neurologic Manifestations Down Syndrome Congenital Abnormalities Dementia Neurobehavioral Manifestations Delirium |
Nootropic Agents Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors |
Cholinergic Agents Pharmacologic Actions Cholinesterase Inhibitors Pathologic Processes Therapeutic Uses Syndrome Central Nervous System Agents |