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Sponsors and Collaborators: |
Eisai Inc. Pfizer |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00570128 |
The purpose of this study is to determine whether donepezil HCl is effective and safe in improving cognitive dysfunction exhibited by children and adolescents with Down syndrome. Effectiveness will be measured by rating communication, daily living skills, and social skills and relationships in subjects aged 10 to 17.
Condition | Intervention | Phase |
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Down Syndrome |
Drug: Donepezil hydrochloride Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, 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 |
Estimated Enrollment: | 150 |
Study Start Date: | December 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Donepezil hydrochloride
Oral liquid.
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2: Placebo Comparator |
Drug: Placebo
Oral liquid.
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Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Anita Murthy | Eisai Inc. |
Responsible Party: | Eisai Inc. ( Eisai Medical Services ) |
Study ID Numbers: | E2020-A001-219 |
Study First Received: | December 6, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00570128 |
Health Authority: | United States: Food and Drug Administration |
Down Syndrome trisomy 21 |
Chromosomal abnormalities Mental Retardation Genetic Diseases, Inborn Donepezil Chromosome Disorders Abnormalities, Multiple |
Neurologic Manifestations Trisomy Down Syndrome Congenital Abnormalities Neurobehavioral Manifestations |
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 |