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Evaluating The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00675025
Recruitment Status : Terminated (Sufficient evidence of efficacy not met. Discontinuation not based on any safety concerns.)
First Posted : May 8, 2008
Last Update Posted : December 11, 2008
Information provided by:
Eisai Inc.

Brief Summary:
The purpose of this study is to determine the safety of donepezil hydrochloride (Aricept) in children with Down syndrome who have finished the preceding 10-week, double-blind study of donepezil hydrochloride. Medical tests for drug safety will be conducted at each clinic visit.

Condition or disease Intervention/treatment Phase
Down Syndrome Drug: Donepezil Hydrochloride (Aricept) Phase 2

Detailed Description:
All children in this study will take donepezil hydrochloride once a day, and will come back to the clinic at 8, 24 and 42 weeks after the study has begun. In between these clinic visits, the clinical staff will telephone the child's parent or caregiver to discuss drug safety observations and possible changes in drug dose. At the end of the study (42 weeks), psychological testing will also be given to determine how well the child is functioning.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study To Evaluate The Safety Of Donepezil Hydrochloride (Aricept) For Up To 1 Year In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome - Follow-Up To A 10-Week, Double-Blind, Placebo-Controlled Trial
Study Start Date : April 2008
Estimated Primary Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
Experimental: 1 Drug: Donepezil Hydrochloride (Aricept)
Liquid form Aricept - 5 mg/5 mL donepezil hydrochloride.
Other Name: Aricept

Primary Outcome Measures :
  1. Physical and neurological exams, clinical labs, ECG, Conmeds, Adverse Events, Serious Adverse Events. [ Time Frame: Visit 1 (baseline); Phone Visit (weeks 2,4,6); Visit 2. ]

Secondary Outcome Measures :
  1. Vinland II Adaptive Behavior Scale; Parent /Caregiver Rating Form. [ Time Frame: Visit 1 (baseline); Visit 4 (week 42). ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of Down syndrome (established during study E2020-A001-220).
  • Completion of study E2020-A001-219 (also known as A2501059) with no ongoing SAEs and no severe drug reactions.

Exclusion Criteria:

  • Weight less than 20 kg.
  • Clinically significant conditions affecting absorption, distribution or metabolism of the study medication.
  • No reliable parent or caregiver, or unwillingness or inability of parent or caregiver to fulfill the requirements of the study.
  • Females of childbearing potential who are not practicing an effective means of birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00675025

  Hide Study Locations
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United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
United States, Arkansas
Child Neurology Associates, PC
Little Rock, Arkansas, United States, 72205
United States, California
Midwest Children's Health Research Institute
Los Angeles, California, United States, 90048
Children's Hospital and Research Center at Oakland
Oakland, California, United States, 94609
University of California, Irvine Medical Center
Orange, California, United States, 92868
UCSD Pediatric Pharmacology Research Unit
San Diego, California, United States, 92123
United States, Colorado
Rocky Mountain Pediatrics, P.C.
Lakewood, Colorado, United States, 80214
United States, Florida
Neufeld Medical Group, Inc.
Fort Myers, Florida, United States, 33912
Miami Children's Hospital
Miami, Florida, United States, 33155-3009
Miami Children's Hospital - Medical Genetics and Neuro-Developmental Center
Miami, Florida, United States, 33155
Phoenix Children's Hospital
Miami, Florida, United States, 33155
Clinical Studies Centers, LLC
St. Petersburg, Florida, United States, 33709
Northwest Clinical Research Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
Road Runner Research
Atlanta, Georgia, United States, 30342
United States, Michigan
Hurley Medical Center
Flint, Michigan, United States, 48503
Saint Mary's Health Care
Grand Rapids, Michigan, United States, 49503
Washington University School of Medicine
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Regions Hospital
Saint Paul, Minnesota, United States, 55101-2595
United States, Missouri
Northwest Clinical Research Center
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Meridien Research
Lincoln, Nebraska, United States, 68504
United States, New Jersey
Clinical Research Center of New Jersey
Voorhees, New Jersey, United States, 08043
United States, North Carolina
Division of Genetics and Developmental Behavior
Durham, North Carolina, United States, 27710
United States, Ohio
Metrohealth Medical Center
Cleveland, Ohio, United States, 44109
Valko and Associates
Toledo, Ohio, United States, 43606
United States, Oklahoma
Office of Lazlo Mate
Tulsa, Oklahoma, United States, 74104
United States, South Carolina
Medical Univ of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-9225
United States, Texas
Down Syndrome Clinic of Houston
Houston, Texas, United States, 77030
Alamo City Clinical Research, LLC
San Antonio, Texas, United States, 78258
Community Research Foundation
San Antonio, Texas, United States, 78258
United States, Washington
Neuropsychiatric Research Center of Southwest Florida
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Eisai Inc.
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Study Director: Anita Murthy, PharmD Eisai Inc.

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Responsible Party: Yvonne Noble, Study Manager, Eisai Inc. Identifier: NCT00675025     History of Changes
Other Study ID Numbers: E2020-A001-220
First Posted: May 8, 2008    Key Record Dates
Last Update Posted: December 11, 2008
Last Verified: December 2008
Additional relevant MeSH terms:
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Down Syndrome
Cognitive Dysfunction
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents